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FDA 510(k)

MAICO MA53

K-Number: K981142 · 1998-04-22

ApplicantBernafon-Maico, Inc.
Decision Date1998-04-22
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MAICO MA53 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 1998-04-22 under 510(k) number K981142. 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 MA53?

MAICO MA53 is a medical device that received FDA 510(k) clearance on 1998-04-22. The listed applicant is Bernafon-Maico, Inc.. The 510(k) number is K981142.

When did MAICO MA53 receive FDA 510(k) clearance?

MAICO MA53 received FDA 510(k) clearance on 1998-04-22, under 510(k) number K981142.

Who is the listed applicant for MAICO MA53?

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 MA53?

The FDA product code for MAICO MA53 is EWO.

Related Clinical Trials

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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 MA42K974211OPUS 2 - FULL CONCHA SERIES - ITEK974069OPUS 2 - CANAL SERIES (ITC)K974152OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)K973948DUALINE 100 BTEK971158DUALINE 400 CIC

View all 9 devices →

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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