saurabhdubey
Reg_learner
Hi friends,
I would like to know the key difference in 510k type ( traditional vs abbreviated vs special).
My understanding says ;
Traditional - for new device (having a predicated device) and timeline is 90 days.
Special : For a device which is already and approved (OEM) and if made any modification but without changing to intended use, timeline 30 days.
Abbreviated : If any recognized standard specific to the type of your device you are submitting
Please provide your thought on the same.
thanks
saurabh
I would like to know the key difference in 510k type ( traditional vs abbreviated vs special).
My understanding says ;
Traditional - for new device (having a predicated device) and timeline is 90 days.
Special : For a device which is already and approved (OEM) and if made any modification but without changing to intended use, timeline 30 days.
Abbreviated : If any recognized standard specific to the type of your device you are submitting
Please provide your thought on the same.
thanks
saurabh