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FDA 510(k)

ELEGANCE - KED, BEHIND THE EAR HEARING AID

K-Number: K913771 · 1991-09-18

ApplicantQualitone
Decision Date1991-09-18
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ELEGANCE - KED, BEHIND THE EAR HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Qualitone. It received FDA 510(k) clearance on 1991-09-18 under 510(k) number K913771. 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 ELEGANCE - KED, BEHIND THE EAR HEARING AID?

ELEGANCE - KED, BEHIND THE EAR HEARING AID is a medical device that received FDA 510(k) clearance on 1991-09-18. The listed applicant is Qualitone. The 510(k) number is K913771.

When did ELEGANCE - KED, BEHIND THE EAR HEARING AID receive FDA 510(k) clearance?

ELEGANCE - KED, BEHIND THE EAR HEARING AID received FDA 510(k) clearance on 1991-09-18, under 510(k) number K913771.

Who is the listed applicant for ELEGANCE - KED, BEHIND THE EAR HEARING AID?

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

What is the FDA product code for ELEGANCE - KED, BEHIND THE EAR HEARING AID?

The FDA product code for ELEGANCE - KED, BEHIND THE EAR HEARING AID is ESD.

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Other records listing Qualitone 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.

K961827IN-THE-EARK955466DYNAMEQ-II OPTIONK955359CYBER III OPTION UM, UC312, UC10, UCICK953884PROPHETK935348ODYSSEY CLINICAL AUDIOMETERK935289PRO FIT-CYBER II OPTION

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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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