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FDA 510(k)

MAICO IN-THE-EAR MODEL RD 201

K-Number: K946253 · 1995-01-30

ApplicantMaico Hearing Instruments, Inc.
Decision Date1995-01-30
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MAICO IN-THE-EAR MODEL RD 201 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 1995-01-30 under 510(k) number K946253. 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 MAICO IN-THE-EAR MODEL RD 201?

MAICO IN-THE-EAR MODEL RD 201 is a medical device that received FDA 510(k) clearance on 1995-01-30. The listed applicant is Maico Hearing Instruments, Inc.. The 510(k) number is K946253.

When did MAICO IN-THE-EAR MODEL RD 201 receive FDA 510(k) clearance?

MAICO IN-THE-EAR MODEL RD 201 received FDA 510(k) clearance on 1995-01-30, under 510(k) number K946253.

Who is the listed applicant for MAICO IN-THE-EAR MODEL RD 201?

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 MAICO IN-THE-EAR MODEL RD 201?

The FDA product code for MAICO IN-THE-EAR MODEL RD 201 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 CICK931322KS 5 - CLINICAL AUDIOMETERK933291MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID

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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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