The following data is part of a premarket notification filed by Axonics, Inc. with the FDA for Audit V Ax 135.
Device ID | K833298 |
510k Number | K833298 |
Device Name: | AUDIT V AX 135 |
Classification | Conditioner, Signal, Physiological |
Applicant | AXONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GWK |
CFR Regulation Number | 882.1845 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-23 |
Decision Date | 1983-12-01 |