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FDA 510(k)

INEARSET IES HEARING AID

K-Number: K862222 · 1986-07-16

ApplicantInearset, Inc.
Decision Date1986-07-16
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INEARSET IES HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Inearset, Inc.. It received FDA 510(k) clearance on 1986-07-16 under 510(k) number K862222. 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 INEARSET IES HEARING AID?

INEARSET IES HEARING AID is a medical device that received FDA 510(k) clearance on 1986-07-16. The listed applicant is Inearset, Inc.. The 510(k) number is K862222.

When did INEARSET IES HEARING AID receive FDA 510(k) clearance?

INEARSET IES HEARING AID received FDA 510(k) clearance on 1986-07-16, under 510(k) number K862222.

Who is the listed applicant for INEARSET IES HEARING AID?

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

What is the FDA product code for INEARSET IES HEARING AID?

The FDA product code for INEARSET IES HEARING AID is ESD.

Related Clinical Trials

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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