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FDA 510(k)

BEHIND-THE-EAR HEARING AID SERIES G

K-Number: K801062 · 1980-06-04

ApplicantMaico Hearing Instruments, Inc.
Decision Date1980-06-04
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BEHIND-THE-EAR HEARING AID SERIES G is the device name listed in this FDA 510(k) record. The listed applicant is Maico Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1980-06-04 under 510(k) number K801062. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEHIND-THE-EAR HEARING AID SERIES G?

BEHIND-THE-EAR HEARING AID SERIES G is a medical device that received FDA 510(k) clearance on 1980-06-04. The listed applicant is Maico Hearing Instruments, Inc.. The 510(k) number is K801062.

When did BEHIND-THE-EAR HEARING AID SERIES G receive FDA 510(k) clearance?

BEHIND-THE-EAR HEARING AID SERIES G received FDA 510(k) clearance on 1980-06-04, under 510(k) number K801062.

Who is the listed applicant for BEHIND-THE-EAR HEARING AID SERIES G?

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

What is the FDA product code for BEHIND-THE-EAR HEARING AID SERIES G?

The FDA product code for BEHIND-THE-EAR HEARING AID SERIES G is ESD.

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Other records listing Maico Hearing Instruments, 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.

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Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, 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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