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FDA 510(k)

BERNAFON COLIBRI, C-2H HEARING AIDS

K-Number: K874589 · 1987-12-04

ApplicantBernafon, Inc.
Decision Date1987-12-04
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BERNAFON COLIBRI, C-2H HEARING AIDS is the device name listed in this FDA 510(k) record. The listed applicant is Bernafon, Inc.. It received FDA 510(k) clearance on 1987-12-04 under 510(k) number K874589. 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 BERNAFON COLIBRI, C-2H HEARING AIDS?

BERNAFON COLIBRI, C-2H HEARING AIDS is a medical device that received FDA 510(k) clearance on 1987-12-04. The listed applicant is Bernafon, Inc.. The 510(k) number is K874589.

When did BERNAFON COLIBRI, C-2H HEARING AIDS receive FDA 510(k) clearance?

BERNAFON COLIBRI, C-2H HEARING AIDS received FDA 510(k) clearance on 1987-12-04, under 510(k) number K874589.

Who is the listed applicant for BERNAFON COLIBRI, C-2H HEARING AIDS?

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 BERNAFON COLIBRI, C-2H HEARING AIDS?

The FDA product code for BERNAFON COLIBRI, C-2H HEARING AIDS is ESD.

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Other records listing Bernafon, 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.

K880349MODEL 759 CUSTOM IN-THE-EAR HEARING AIDK864823BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1K864180INTEGRA, CUSTOM IN-THE-EAR HEARING AIDK860759CHARISMA HEARING AIDK855240BEHIND THE EAR HEARING AIDS MODELK851547BEHIND THE EAR HEARING AID MODEL BERNAFON T-82

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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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