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FDA 510(k)

MAICO MA52

K-Number: K971080 · 1997-06-06

ApplicantBernafon-Maico, Inc.
Decision Date1997-06-06
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MAICO MA52 is the device name listed in this FDA 510(k) record. The listed applicant is Bernafon-Maico, Inc.. It received FDA 510(k) clearance on 1997-06-06 under 510(k) number K971080. 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 MAICO MA52?

MAICO MA52 is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is Bernafon-Maico, Inc.. The 510(k) number is K971080.

When did MAICO MA52 receive FDA 510(k) clearance?

MAICO MA52 received FDA 510(k) clearance on 1997-06-06, under 510(k) number K971080.

Who is the listed applicant for MAICO MA52?

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

What is the FDA product code for MAICO MA52?

The FDA product code for MAICO MA52 is EWO.

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Other records listing Bernafon-Maico, 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.

K982723MAICO MA42K981142MAICO MA53K974211OPUS 2 - FULL CONCHA SERIES - ITEK974069OPUS 2 - CANAL SERIES (ITC)K974152OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)K973948DUALINE 100 BTE

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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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