The following data is part of a premarket notification filed by Axonics, Inc. with the FDA for Audit Tm V.
| Device ID | K843712 |
| 510k Number | K843712 |
| Device Name: | AUDIT TM V |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | AXONICS, INC. 1500 SALADO DRIVE Mountain View , CA 94043 - |
| Contact | John Lee |
| Correspondent | John Lee AXONICS, INC. 1500 SALADO DRIVE Mountain View , CA 94043 - |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-21 |
| Decision Date | 1985-04-05 |