AUDIT V AX 135

Conditioner, Signal, Physiological

AXONICS, INC.

The following data is part of a premarket notification filed by Axonics, Inc. with the FDA for Audit V Ax 135.

Pre-market Notification Details

Device IDK833298
510k NumberK833298
Device Name:AUDIT V AX 135
ClassificationConditioner, Signal, Physiological
Applicant AXONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGWK  
CFR Regulation Number882.1845 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-23
Decision Date1983-12-01

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