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FDA 510(k)

AUDIT

K-Number: K822335 · 1983-02-07

ApplicantAxonics, Inc.
Decision Date1983-02-07
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIT is the device name listed in this FDA 510(k) record. The listed applicant is Axonics, Inc.. It received FDA 510(k) clearance on 1983-02-07 under 510(k) number K822335. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDIT?

AUDIT is a medical device that received FDA 510(k) clearance on 1983-02-07. The listed applicant is Axonics, Inc.. The 510(k) number is K822335.

When did AUDIT receive FDA 510(k) clearance?

AUDIT received FDA 510(k) clearance on 1983-02-07, under 510(k) number K822335.

Who is the listed applicant for AUDIT?

The FDA 510(k) record lists Axonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUDIT?

The FDA product code for AUDIT is EWO.

Related Clinical Trials

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Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 42095631Ethical concerns regarding a lack of standardized clinical demographic data: an audit of 2023 FDA medical devices.Expert review of medical devices ()PMID: 41716615An auditable and source-verified framework for clinical AI decision support: integrating retrieval-augmented generation with data provenance.Frontiers in artificial intelligence ()

Other records listing Axonics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K843712AUDIT TM VK833298AUDIT V AX 135K831870ALLERGENETICS FLUORO-FAST READERK823494TOTAL IGE-FAST TEST

Related Devices (Code: EWO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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