The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Stand Alone Cystometrogram.
| Device ID | K934141 |
| 510k Number | K934141 |
| Device Name: | STAND ALONE CYSTOMETROGRAM |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst MEDICAL ENGINEERING CORP. 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 | 1993-08-25 |
| Decision Date | 1993-11-18 |