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FDA 510(k)

AIR CONDUCTION HEARING AID

K-Number: K973846 · 1997-10-29

ApplicantBaron Trading, Inc.
Decision Date1997-10-29
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AIR CONDUCTION HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Baron Trading, Inc.. It received FDA 510(k) clearance on 1997-10-29 under 510(k) number K973846. 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 AIR CONDUCTION HEARING AID?

AIR CONDUCTION HEARING AID is a medical device that received FDA 510(k) clearance on 1997-10-29. The listed applicant is Baron Trading, Inc.. The 510(k) number is K973846.

When did AIR CONDUCTION HEARING AID receive FDA 510(k) clearance?

AIR CONDUCTION HEARING AID received FDA 510(k) clearance on 1997-10-29, under 510(k) number K973846.

Who is the listed applicant for AIR CONDUCTION HEARING AID?

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

What is the FDA product code for AIR CONDUCTION HEARING AID?

The FDA product code for AIR CONDUCTION HEARING AID 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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