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FDA 510(k)

CHARISMA HEARING AID

K-Number: K860759 · 1986-04-11

ApplicantBernafon, Inc.
Decision Date1986-04-11
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CHARISMA HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Bernafon, Inc.. It received FDA 510(k) clearance on 1986-04-11 under 510(k) number K860759. 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 CHARISMA HEARING AID?

CHARISMA HEARING AID is a medical device that received FDA 510(k) clearance on 1986-04-11. The listed applicant is Bernafon, Inc.. The 510(k) number is K860759.

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

CHARISMA HEARING AID received FDA 510(k) clearance on 1986-04-11, under 510(k) number K860759.

Who is the listed applicant for CHARISMA HEARING AID?

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 CHARISMA HEARING AID?

The FDA product code for CHARISMA HEARING AID 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 AIDK874589BERNAFON COLIBRI, C-2H HEARING AIDSK864823BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1K864180INTEGRA, CUSTOM IN-THE-EAR HEARING AIDK855240BEHIND THE EAR HEARING AIDS MODELK851547BEHIND THE EAR HEARING AID MODEL BERNAFON T-82

View all 16 devices →

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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