codes
Device Classification Name |
oximeter |
|||
---|---|---|---|---|
510(k) Number | K001708 | |||
Device Name | PROFOX SOFTWARE, MODEL 920M-41 | |||
Original Applicant |
|
|||
Original Contact | gerry richardson | |||
Regulation Number | 870.2700 | |||
Classification Product Code |
|
|||
Date Received | 06/05/2000 | |||
Decision Date | 03/01/2001 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Cardiovascular |
|||
510k Review Panel |
Anesthesiology |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |