R
Hi,
We are new to Manufacturing ECG Monitors.
We are planning to Submit the FDA 510 (k) through Substantial Equivalence by comparing with the other ECG Monitors.
We are now preparing the format according to the Guidance for Industry - Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement).
Is this the better way to submit the approval for the 510 (k)?
else
if we choose to submit the file through Comparison Testing with the Predicate Devices....what all the tests we have to do....should be do the clinical testing also!
Waiting for the reply.....................please help us
We are new to Manufacturing ECG Monitors.
We are planning to Submit the FDA 510 (k) through Substantial Equivalence by comparing with the other ECG Monitors.
We are now preparing the format according to the Guidance for Industry - Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement).
Is this the better way to submit the approval for the 510 (k)?
else
if we choose to submit the file through Comparison Testing with the Predicate Devices....what all the tests we have to do....should be do the clinical testing also!
Waiting for the reply.....................please help us