The following data is part of a premarket notification filed by Bowen Medical Services, Inc. with the FDA for Cuff Guard.
| Device ID | K952825 |
| 510k Number | K952825 |
| Device Name: | CUFF GUARD |
| Classification | Blood Pressure Cuff |
| Applicant | BOWEN MEDICAL SERVICES, INC. 1525 NORTH OHIO AVE. SUITE 6 Live Oak, FL 32060 |
| Contact | H. Clay Wilson |
| Correspondent | H. Clay Wilson BOWEN MEDICAL SERVICES, INC. 1525 NORTH OHIO AVE. SUITE 6 Live Oak, FL 32060 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-20 |
| Decision Date | 1995-09-15 |