Audit V Ax 135

FDA 510(k) K833298 · Axonics, Inc.

Substantially Equivalent

510(k) numberK833298

Submission

Device name
Audit V Ax 135
Applicant
Axonics, Inc.
Mchenry, IL, US
Received
September 23, 1983
Decision date
December 1, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GWK – Conditioner, Signal, Physiological
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1845
Specialty
Neurology

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Questions and answers

When was Audit V Ax 135 cleared by the FDA?

Audit V Ax 135 (K833298) received a 510(k) decision of Substantially Equivalent on December 1, 1983, 69 days after the submission was received.

What is the product code of K833298?

The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.