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FDA 510(k)

OTOMET MODEL M-9 HEARING INSTRUMENT

K-Number: K820425 · 1982-03-02

ApplicantOtomet Corp.
Decision Date1982-03-02
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOMET MODEL M-9 HEARING INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Otomet Corp.. It received FDA 510(k) clearance on 1982-03-02 under 510(k) number K820425. 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 OTOMET MODEL M-9 HEARING INSTRUMENT?

OTOMET MODEL M-9 HEARING INSTRUMENT is a medical device that received FDA 510(k) clearance on 1982-03-02. The listed applicant is Otomet Corp.. The 510(k) number is K820425.

When did OTOMET MODEL M-9 HEARING INSTRUMENT receive FDA 510(k) clearance?

OTOMET MODEL M-9 HEARING INSTRUMENT received FDA 510(k) clearance on 1982-03-02, under 510(k) number K820425.

Who is the listed applicant for OTOMET MODEL M-9 HEARING INSTRUMENT?

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

What is the FDA product code for OTOMET MODEL M-9 HEARING INSTRUMENT?

The FDA product code for OTOMET MODEL M-9 HEARING INSTRUMENT is ESD.

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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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