The following data is part of a premarket notification filed by Browne Medical, Inc. with the FDA for Urobei Stress Incontinence Monitor.
| Device ID | K851483 |
| 510k Number | K851483 |
| Device Name: | UROBEI STRESS INCONTINENCE MONITOR |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | BROWNE MEDICAL, INC. 1035 CINDY LN. Carpinteria, CA |
| Contact | Maureen Wright |
| Correspondent | Maureen Wright BROWNE MEDICAL, INC. 1035 CINDY LN. Carpinteria, CA |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-08-07 |