The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Urethral Pressure Profile & Temp. Modul.
| Device ID | K823561 |
| 510k Number | K823561 |
| Device Name: | URETHRAL PRESSURE PROFILE & TEMP. MODUL |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-02 |
| Decision Date | 1983-01-07 |