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FDA 510(k)

BEHING-THE-EAR HEARING AID T-85D

K-Number: K840479 · 1984-03-30

ApplicantBernafon, Inc.
Decision Date1984-03-30
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BEHING-THE-EAR HEARING AID T-85D is the device name listed in this FDA 510(k) record. The listed applicant is Bernafon, Inc.. It received FDA 510(k) clearance on 1984-03-30 under 510(k) number K840479. 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 BEHING-THE-EAR HEARING AID T-85D?

BEHING-THE-EAR HEARING AID T-85D is a medical device that received FDA 510(k) clearance on 1984-03-30. The listed applicant is Bernafon, Inc.. The 510(k) number is K840479.

When did BEHING-THE-EAR HEARING AID T-85D receive FDA 510(k) clearance?

BEHING-THE-EAR HEARING AID T-85D received FDA 510(k) clearance on 1984-03-30, under 510(k) number K840479.

Who is the listed applicant for BEHING-THE-EAR HEARING AID T-85D?

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

What is the FDA product code for BEHING-THE-EAR HEARING AID T-85D?

The FDA product code for BEHING-THE-EAR HEARING AID T-85D is ESD.

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Other records listing Bernafon, Inc. as applicant

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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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