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FDA 510(k)

MAICO MA25 SERIES II WITH SPEECH

K-Number: K962275 · 1996-09-05

ApplicantBernafon-Maico, Inc.
Decision Date1996-09-05
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MAICO MA25 SERIES II WITH SPEECH 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 1996-09-05 under 510(k) number K962275. 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 MA25 SERIES II WITH SPEECH?

MAICO MA25 SERIES II WITH SPEECH is a medical device that received FDA 510(k) clearance on 1996-09-05. The listed applicant is Bernafon-Maico, Inc.. The 510(k) number is K962275.

When did MAICO MA25 SERIES II WITH SPEECH receive FDA 510(k) clearance?

MAICO MA25 SERIES II WITH SPEECH received FDA 510(k) clearance on 1996-09-05, under 510(k) number K962275.

Who is the listed applicant for MAICO MA25 SERIES II WITH SPEECH?

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 MA25 SERIES II WITH SPEECH?

The FDA product code for MAICO MA25 SERIES II WITH SPEECH 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 MA53K974152OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)K974211OPUS 2 - FULL CONCHA SERIES - ITEK974069OPUS 2 - CANAL SERIES (ITC)K973948DUALINE 100 BTE

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Related Devices (Code: EWO)

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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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