The following data is part of a premarket notification filed by Surgitek with the FDA for Om-4 (tenative) Urodynamic Measruement System.
| Device ID | K944391 |
| 510k Number | K944391 |
| Device Name: | OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-09 |
| Decision Date | 1995-02-07 |