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FDA 510(k)

AHL, ITE MODEL AMERICAN

K-Number: K910325 · 1991-04-15

ApplicantBob Bare Hearing Aid Repair
Decision Date1991-04-15
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AHL, ITE MODEL AMERICAN is the device name listed in this FDA 510(k) record. The listed applicant is Bob Bare Hearing Aid Repair. It received FDA 510(k) clearance on 1991-04-15 under 510(k) number K910325. 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 AHL, ITE MODEL AMERICAN?

AHL, ITE MODEL AMERICAN is a medical device that received FDA 510(k) clearance on 1991-04-15. The listed applicant is Bob Bare Hearing Aid Repair. The 510(k) number is K910325.

When did AHL, ITE MODEL AMERICAN receive FDA 510(k) clearance?

AHL, ITE MODEL AMERICAN received FDA 510(k) clearance on 1991-04-15, under 510(k) number K910325.

Who is the listed applicant for AHL, ITE MODEL AMERICAN?

The FDA 510(k) record lists Bob Bare Hearing Aid Repair as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AHL, ITE MODEL AMERICAN?

The FDA product code for AHL, ITE MODEL AMERICAN is ESD.

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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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