The following data is part of a premarket notification filed by Browne Medical, Inc. with the FDA for Urometer.
| Device ID | K833043 |
| 510k Number | K833043 |
| Device Name: | UROMETER |
| Classification | Device, Urine Flow Rate Measuring, Non-electrical, Disposable |
| Applicant | BROWNE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FFG |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-06 |
| Decision Date | 1984-02-04 |