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FDA 510(k)

HEARING AID, DM IROS DIRECTIONAL

K-Number: K770308 · 1977-02-28

ApplicantMaico Hearing Instruments, Inc.
Decision Date1977-02-28
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AID, DM IROS DIRECTIONAL 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 1977-02-28 under 510(k) number K770308. 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 HEARING AID, DM IROS DIRECTIONAL?

HEARING AID, DM IROS DIRECTIONAL is a medical device that received FDA 510(k) clearance on 1977-02-28. The listed applicant is Maico Hearing Instruments, Inc.. The 510(k) number is K770308.

When did HEARING AID, DM IROS DIRECTIONAL receive FDA 510(k) clearance?

HEARING AID, DM IROS DIRECTIONAL received FDA 510(k) clearance on 1977-02-28, under 510(k) number K770308.

Who is the listed applicant for HEARING AID, DM IROS DIRECTIONAL?

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 HEARING AID, DM IROS DIRECTIONAL?

The FDA product code for HEARING AID, DM IROS DIRECTIONAL 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.

K960031AUDIOFLEX 120K954054MAICO PRODIGY CIC SERIESK953161MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTIONK950637MAICO IN-THE-EAR MODEL RD-312 CICK946253MAICO IN-THE-EAR MODEL RD 201K931322KS 5 - CLINICAL AUDIOMETER

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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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