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FDA 510(k)

HORN CUSTOM AID

K-Number: K873338 · 1987-09-04

ApplicantHearing Aids by Guy Horn
Decision Date1987-09-04
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HORN CUSTOM AID is the device name listed in this FDA 510(k) record. The listed applicant is Hearing Aids by Guy Horn. It received FDA 510(k) clearance on 1987-09-04 under 510(k) number K873338. 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 HORN CUSTOM AID?

HORN CUSTOM AID is a medical device that received FDA 510(k) clearance on 1987-09-04. The listed applicant is Hearing Aids by Guy Horn. The 510(k) number is K873338.

When did HORN CUSTOM AID receive FDA 510(k) clearance?

HORN CUSTOM AID received FDA 510(k) clearance on 1987-09-04, under 510(k) number K873338.

Who is the listed applicant for HORN CUSTOM AID?

The FDA 510(k) record lists Hearing Aids by Guy Horn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HORN CUSTOM AID?

The FDA product code for HORN CUSTOM AID is ESD.

Related Clinical Trials

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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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