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FDA 510(k)

INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR

K-Number: K872647 · 1987-08-26

ApplicantInt'L Hearing Aids, Inc.
Decision Date1987-08-26
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR 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 1987-08-26 under 510(k) number K872647. 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 INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR?

INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR is a medical device that received FDA 510(k) clearance on 1987-08-26. The listed applicant is Int'L Hearing Aids, Inc.. The 510(k) number is K872647.

When did INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR receive FDA 510(k) clearance?

INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR received FDA 510(k) clearance on 1987-08-26, under 510(k) number K872647.

Who is the listed applicant for INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR?

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 INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR?

The FDA product code for INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR 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.

K873800INTERNATIONAL MODEL XM BEHIND-THE-EARK873799INTERNATIONAL MODEL XL BEHIND-THE-EARK873798INTERNATIONAL MODEL XP BEHIND-THE-EARK864028MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AIDK864030MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AIDK864031MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID

View all 21 devices →

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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