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 |