FDA 510(k)

AT-2

K-Number: K923007 · 1993-02-26

Decision Date1993-02-26

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

AT-2 is the device name listed in this FDA 510(k) record. The listed applicant is Qualitone. It received FDA 510(k) clearance on 1993-02-26 under 510(k) number K923007. 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 AT-2?

AT-2 is a medical device that received FDA 510(k) clearance on 1993-02-26. The listed applicant is Qualitone. The 510(k) number is K923007.

When did AT-2 receive FDA 510(k) clearance?

AT-2 received FDA 510(k) clearance on 1993-02-26, under 510(k) number K923007.

Who is the listed applicant for AT-2?

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

What is the FDA product code for AT-2?

The FDA product code for AT-2 is EWO.

Other records listing Qualitone 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.

K961827IN-THE-EAR K955466DYNAMEQ-II OPTION K955359CYBER III OPTION UM, UC312, UC10, UCIC K953884PROPHET K935348ODYSSEY CLINICAL AUDIOMETER K935289PRO FIT-CYBER II OPTION

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Related Devices (Code: EWO)

K234095OtoNova/OtoNova ProOtodynamics K240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH K191372LyraInteracoustics A/S K180287GSI 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.