The following data is part of a premarket notification filed by Browne Medical Systems, Inc. with the FDA for Model 8100 Urodynamics Measuring System.
| Device ID | K921047 |
| 510k Number | K921047 |
| Device Name: | MODEL 8100 URODYNAMICS MEASURING SYSTEM |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | BROWNE MEDICAL SYSTEMS, INC. 8990 SPRINGBROOK DRIVE, SUITE 120 Minneapolis, MN 55433 |
| Contact | Al Sherwood |
| Correspondent | Al Sherwood BROWNE MEDICAL SYSTEMS, INC. 8990 SPRINGBROOK DRIVE, SUITE 120 Minneapolis, MN 55433 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-14 |
| Decision Date | 1992-04-10 |