SBS - The best value in QMS software

Blood Glucose Monitor - Sample 510(k) submission application

P

paullarn

#1
Hi,
we are a small company never filed for a 510K. Does anyone have a simple sample application we can use as reference?
Thanks in advance.
PS WeI really need to see a small, simple, yet complete app.

Regards,
Paul
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
AnaMariaVR2 FDA OKs Bluetooth-enabled blood glucose monitor from LifeScan US Food and Drug Administration (FDA) 5
I Blood Glucose Monitor & its Logbook Website - Do I need to get 510k for the Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Applying for 510(k) Submission for Blood Glucose Monitor System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Establishment Register Question - Subcontracting - Blood Glucose Monitor System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
C Can Blood Glucose Monitor Test Strips be sold individually? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
M 2016 FDA Final Guidance for Blood Glucose Monitoring Systems - Implementation Other US Medical Device Regulations 2
J Blood glucose monitoring device testing - GLP or GCP Other US Medical Device Regulations 1
P ISO 15197:2013 (Blood glucose monitoring system) was released in May Other US Medical Device Regulations 10
Ronen E Abbott Voluntary Recall of FreeStyle lnsulinx? Blood Glucose Meters Other Medical Device and Orthopedic Related Topics 0
P Do we need to submit Special 510K for a Blood Glucose System? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R IEC 61010 vs IEC 60601-1 to ISO 15197 - Blood glucose monitoring device IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
Aliken Container for the blood bags and medicines EU Medical Device Regulations 2
S How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping Other Medical Device Related Standards 6
R Industrial accidents - Cleanup & disposal of blood spill Occupational Health & Safety Management Standards 1
M Vacuum Blood Collection Tubes EU Medical Device Regulations 1
T To Identify the Applicable MDD Directive - Prepared blood smear EU Medical Device Regulations 13
F Biocompatibility Device Categorization: Priming with Blood Other Medical Device Related Standards 1
A FDA Blood Pressure Monitoring Equipment Measurement Requirements US Food and Drug Administration (FDA) 1
B What is the safe Temperature Limit for Medical Device with blood contact ? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A German MTK (MPBetreibV ? 11) Blood Pressure Meter Requirements EU Medical Device Regulations 2
D How to handle a blood stained GMP document ? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
C What would be the Device Classification for a Blood Pressure Monitor in EU ? EU Medical Device Regulations 3
R Applicable Medical Device Standards for Home Use Blood Pressure Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Thermal Sensitivity Testing - Heat Lamp - ILY - Increased blood circulation IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Blood Collection Inventory Control Procedure example wanted Business Continuity & Resiliency Planning (BCRP) 3
R Classification of Applied Parts - Blood Measurement Sensors IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
S FMEA and Control Plan in a Cord Blood Bank FMEA and Control Plans 2
H Blood Banking (CFR 21 PART 606) Change Control Requirements US Food and Drug Administration (FDA) 8
H Validated Software - IND study to get a BLA (Blood Analysis Device) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Phthalate Free Products - Risk Management of a device that holds blood EU Medical Device Regulations 3
R Blood Pressure Transducers - Need to perform EMC test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
B Blood Bag Classification - with Disposable Centrifugal Unit for processing blood EU Medical Device Regulations 4
D Regulation for importation of Blood Collection Set into India Other Medical Device Regulations World-Wide 1
N Sterilisation of IV Bags used for Veterinary Blood Plasma Products ISO 13485:2016 - Medical Device Quality Management Systems 7
D Windows CE Operating System - Implantable Blood Pump and a Software Accessory Device IEC 62304 - Medical Device Software Life Cycle Processes 8
P Standards related to ER Checklist for Blood Grouping Reagents CE Marking (Conformité Européene) / CB Scheme 2
D Off Label Usage (Class II Medical Device - Blood Bank Software) US Food and Drug Administration (FDA) 3
B IVD Laboratory Blood Processor - Applicable standards? IEC61010-1, -2-101? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Classification (Medical Device or Drug) of Blood Bag in Japan Japan Medical Device Regulations 6
E US FDA Blood Loss Policy - Dislodged Hemodialysis Needle Other US Medical Device Regulations 3
A Regulation for manufacturing & marketing external Blood Test Diagnostic Kit in India Other Medical Device Regulations World-Wide 2
Michael Malis Blood Temperature Monitoring for Transportation General Measurement Device and Calibration Topics 2
Michael Malis CLSI Proposed Guideline for Validation and Verification of Tubes for Blood Collection US Food and Drug Administration (FDA) 1
W Classification for Blood Lancet in India, Indonesia, Malaysia and Pakistan Other Medical Device Regulations World-Wide 6
Icy Mountain Why You Should Donate Blood... Coffee Break and Water Cooler Discussions 16
C Medical Device "accessory" - Blood pressure monitor (BPM) power supply EU Medical Device Regulations 7
V Is spray painting allowed for non-blood contact medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
D Monitoring the Use of Blood and Blood Products - Meeting the JCI Standards Statistical Analysis Tools, Techniques and SPC 6
R SPOILER: Don't read if you haven't finished Harry Potter and the Mud Blood Prince Coffee Break and Water Cooler Discussions 19

Similar threads

Top Bottom