AUDIT TM V

Stimulator, Electrical, Evoked Response

AXONICS, INC.

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

Pre-market Notification Details

Device IDK843712
510k NumberK843712
Device Name:AUDIT TM V
ClassificationStimulator, Electrical, Evoked Response
Applicant AXONICS, INC. 1500 SALADO DRIVE Mountain View ,  CA  94043 -
ContactJohn Lee
CorrespondentJohn Lee
AXONICS, INC. 1500 SALADO DRIVE Mountain View ,  CA  94043 -
Product CodeGWF  
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-21
Decision Date1985-04-05

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