The following data is part of a premarket notification filed by Myo/kinetic Systems, Inc. with the FDA for Urogram Cystometrogram.
| Device ID | K936041 |
| 510k Number | K936041 |
| Device Name: | UROGRAM CYSTOMETROGRAM |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | MYO/KINETIC SYSTEMS, INC. N84 W13562 LEON RD. Menomonee Falls, WI 53051 |
| Contact | Hassan Hamedi |
| Correspondent | Hassan Hamedi MYO/KINETIC SYSTEMS, INC. N84 W13562 LEON RD. Menomonee Falls, WI 53051 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-20 |
| Decision Date | 1994-04-18 |