The following data is part of a premarket notification filed by Surgitek with the FDA for Surgitek Npt Monitor.
| Device ID | K875333 |
| 510k Number | K875333 |
| Device Name: | SURGITEK NPT MONITOR |
| Classification | Monitor, Penile Tumescence |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Waxberg |
| Correspondent | Waxberg SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | LIL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-30 |
| Decision Date | 1988-04-13 |