The following data is part of a premarket notification filed by Browne Medical, Inc. with the FDA for Profile Urodynamic Monitoring Sys.
| Device ID | K834503 |
| 510k Number | K834503 |
| Device Name: | PROFILE URODYNAMIC MONITORING SYS |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | BROWNE MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-21 |
| Decision Date | 1984-02-21 |