Audit V Ax 135
FDA 510(k)Class II (US FDA 510(k))
by Axonics Inc.
Identifiers
- 510(k) Number
- K833298 FDA 510(k)
- FDA Product Code
- GWK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1845 FDA 510(k)
- Regulation Number
- 882.1845 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Audit V Ax 135 is a Physiological Signal Conditioner, classified under FDA product code GWK. This device modifies physiological signals for recording and processing, facilitating accurate data acquisition in neurological applications.
Supplied as a reusable medical device, the Audit V Ax 135 is intended for use in clinical settings where signal integrity is critical. It holds an FDA 510(k) clearance (K833298) under the Traditional review pathway, with a decision date of December 1, 1983. No additional sterility or MRI safety information is specified in the regulatory data.
Frequently asked questions
What clinical specialties would primarily benefit from using the Audit V Ax 135 in their workflows?
The Audit V Ax 135 is specifically designed for use in neurology applications, where maintaining the integrity of physiological signals is critical. Clinicians in this field—such as neurologists, electrophysiologists, or researchers in neuromuscular or epilepsy studies—would rely on this device to ensure accurate signal conditioning for recording and processing.
Is the Audit V Ax 135 intended for single-use or repeated use in clinical settings?
The Audit V Ax 135 is classified as a reusable medical device, meaning it is engineered for multiple uses within a clinical environment. This design aligns with its role as a physiological signal conditioner, where durability and consistent performance are essential for long-term data acquisition.
How is the device’s regulatory status relevant to purchasing decisions?
The Audit V Ax 135 holds an FDA 510(k) clearance (K833298) under the Traditional review pathway, with a decision date of December 1, 1983. This clearance confirms it is substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness in its intended use as a physiological signal conditioner for neurological applications.
Are there any special handling or storage requirements for the Audit V Ax 135?
The regulatory data does not specify any unique sterility or storage conditions for the Audit V Ax 135 beyond standard practices for reusable medical devices. Since it is reusable, it should be cleaned, disinfected, and stored according to facility protocols to maintain functionality and prevent cross-contamination between uses.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AUDIT V AX 135 (K833298) — FDA 510(k) | Innolitics, Audit V Ax 135 510 (k) FDA Premarket Notification K833298 AXONICS, INC., 510(k) Premarket Notification
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K833298 | Class II | Active |
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Manufacturer
- Manufacturer
- Axonics Inc.
- FDA Applicant
- Axonics, Inc.
Sources (1)
- FDA 510(k) K833298 24 fields · synced Sep 19, 2026