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FDA 510(k)

MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX

K-Number: K882691 · 1988-08-30

ApplicantMaico Hearing Instruments, Inc.
Decision Date1988-08-30
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX 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 1988-08-30 under 510(k) number K882691. 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 MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX?

MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX is a medical device that received FDA 510(k) clearance on 1988-08-30. The listed applicant is Maico Hearing Instruments, Inc.. The 510(k) number is K882691.

When did MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX receive FDA 510(k) clearance?

MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX received FDA 510(k) clearance on 1988-08-30, under 510(k) number K882691.

Who is the listed applicant for MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX?

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 MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX?

The FDA product code for MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX 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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