The following data is part of a premarket notification filed by Influence, Inc. with the FDA for In-probe Ii Urodynamic System.
| Device ID | K983325 |
| 510k Number | K983325 |
| Device Name: | IN-PROBE II URODYNAMIC SYSTEM |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | INFLUENCE, INC. 71 STEVENSON ST., SUITE 1120 San Francisco, CA 94105 |
| Contact | Peter A Bick |
| Correspondent | Peter A Bick INFLUENCE, INC. 71 STEVENSON ST., SUITE 1120 San Francisco, CA 94105 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-22 |
| Decision Date | 1998-11-24 |
| Summary: | summary |