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FDA 510(k)

HEARING AID MODEL 8160U

K-Number: K780822 · 1978-05-31

ApplicantInt'L Hearing Aids, Inc.
Decision Date1978-05-31
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AID MODEL 8160U is the device name listed in this FDA 510(k) record. The listed applicant is Int'L Hearing Aids, Inc.. It received FDA 510(k) clearance on 1978-05-31 under 510(k) number K780822. 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 MODEL 8160U?

HEARING AID MODEL 8160U is a medical device that received FDA 510(k) clearance on 1978-05-31. The listed applicant is Int'L Hearing Aids, Inc.. The 510(k) number is K780822.

When did HEARING AID MODEL 8160U receive FDA 510(k) clearance?

HEARING AID MODEL 8160U received FDA 510(k) clearance on 1978-05-31, under 510(k) number K780822.

Who is the listed applicant for HEARING AID MODEL 8160U?

The FDA 510(k) record lists Int'L Hearing Aids, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEARING AID MODEL 8160U?

The FDA product code for HEARING AID MODEL 8160U is ESD.

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Other records listing Int'L Hearing Aids, 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.

K873799INTERNATIONAL MODEL XL BEHIND-THE-EARK873800INTERNATIONAL MODEL XM BEHIND-THE-EARK873798INTERNATIONAL MODEL XP BEHIND-THE-EARK872647INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EARK864031MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AIDK864028MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR 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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