The following data is part of a premarket notification filed by Myo/kinetic Systems, Inc. with the FDA for Uro-gram Cystomrtrogram With Uroflowmetry.
| Device ID | K944972 |
| 510k Number | K944972 |
| Device Name: | URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY |
| Classification | Uroflowmeter |
| Applicant | MYO/KINETIC SYSTEMS, INC. N. 84 W. 13562 LEON RD. Menomonee Falls, WI 53051 |
| Contact | Hassan Hamedi |
| Correspondent | Hassan Hamedi MYO/KINETIC SYSTEMS, INC. N. 84 W. 13562 LEON RD. Menomonee Falls, WI 53051 |
| Product Code | EXY |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-11 |
| Decision Date | 1995-03-08 |