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FDA 510(k)

QUALITONE ITE GENESIS

K-Number: K904731 · 1990-12-17

ApplicantQualitone
Decision Date1990-12-17
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

QUALITONE ITE GENESIS is the device name listed in this FDA 510(k) record. The listed applicant is Qualitone. It received FDA 510(k) clearance on 1990-12-17 under 510(k) number K904731. 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 QUALITONE ITE GENESIS?

QUALITONE ITE GENESIS is a medical device that received FDA 510(k) clearance on 1990-12-17. The listed applicant is Qualitone. The 510(k) number is K904731.

When did QUALITONE ITE GENESIS receive FDA 510(k) clearance?

QUALITONE ITE GENESIS received FDA 510(k) clearance on 1990-12-17, under 510(k) number K904731.

Who is the listed applicant for QUALITONE ITE GENESIS?

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 QUALITONE ITE GENESIS?

The FDA product code for QUALITONE ITE GENESIS 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

View all 39 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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