The following data is part of a premarket notification filed by Prizm Medical, Inc. with the FDA for Z-watch System.
Device ID | K951727 |
510k Number | K951727 |
Device Name: | Z-WATCH SYSTEM |
Classification | Stimulator, Muscle, Powered |
Applicant | PRIZM MEDICAL, INC. 3050 BUSINESS PARK DR. SUITE A2 Norcross, GA 30071 |
Contact | James Johnson |
Correspondent | James Johnson PRIZM MEDICAL, INC. 3050 BUSINESS PARK DR. SUITE A2 Norcross, GA 30071 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-13 |
Decision Date | 1995-11-21 |