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FDA 510(k)

BEHIND THE EAR HEARING AID MODEL BERNAFON T-82

K-Number: K851547 · 1985-05-29

ApplicantBernafon, Inc.
Decision Date1985-05-29
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BEHIND THE EAR HEARING AID MODEL BERNAFON T-82 is the device name listed in this FDA 510(k) record. The listed applicant is Bernafon, Inc.. It received FDA 510(k) clearance on 1985-05-29 under 510(k) number K851547. 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 BEHIND THE EAR HEARING AID MODEL BERNAFON T-82?

BEHIND THE EAR HEARING AID MODEL BERNAFON T-82 is a medical device that received FDA 510(k) clearance on 1985-05-29. The listed applicant is Bernafon, Inc.. The 510(k) number is K851547.

When did BEHIND THE EAR HEARING AID MODEL BERNAFON T-82 receive FDA 510(k) clearance?

BEHIND THE EAR HEARING AID MODEL BERNAFON T-82 received FDA 510(k) clearance on 1985-05-29, under 510(k) number K851547.

Who is the listed applicant for BEHIND THE EAR HEARING AID MODEL BERNAFON T-82?

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 BEHIND THE EAR HEARING AID MODEL BERNAFON T-82?

The FDA product code for BEHIND THE EAR HEARING AID MODEL BERNAFON T-82 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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