The following data is part of a premarket notification filed by Pelvicare, Inc. with the FDA for Accuset Sensor, Model 2000.
| Device ID | K001386 |
| 510k Number | K001386 |
| Device Name: | ACCUSET SENSOR, MODEL 2000 |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | PELVICARE, INC. 28202 CABOT RD., SUITE 300 Laguna Niguel, CA 92677 |
| Contact | Walter D Wallach |
| Correspondent | Walter D Wallach PELVICARE, INC. 28202 CABOT RD., SUITE 300 Laguna Niguel, CA 92677 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-02 |
| Decision Date | 2000-07-17 |