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FDA 510(k)

CUSTOM PERSONAL EAR - CPE

K-Number: K911497 · 1991-04-19

ApplicantQualitone
Decision Date1991-04-19
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CUSTOM PERSONAL EAR - CPE is the device name listed in this FDA 510(k) record. The listed applicant is Qualitone. It received FDA 510(k) clearance on 1991-04-19 under 510(k) number K911497. 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 CUSTOM PERSONAL EAR - CPE?

CUSTOM PERSONAL EAR - CPE is a medical device that received FDA 510(k) clearance on 1991-04-19. The listed applicant is Qualitone. The 510(k) number is K911497.

When did CUSTOM PERSONAL EAR - CPE receive FDA 510(k) clearance?

CUSTOM PERSONAL EAR - CPE received FDA 510(k) clearance on 1991-04-19, under 510(k) number K911497.

Who is the listed applicant for CUSTOM PERSONAL EAR - CPE?

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 CUSTOM PERSONAL EAR - CPE?

The FDA product code for CUSTOM PERSONAL EAR - CPE 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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