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FDA 510(k)

MULTISONIC (SUPER) CODE TSM

K-Number: K771069 · 1977-06-24

ApplicantQualitone
Decision Date1977-06-24
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MULTISONIC (SUPER) CODE TSM is the device name listed in this FDA 510(k) record. The listed applicant is Qualitone. It received FDA 510(k) clearance on 1977-06-24 under 510(k) number K771069. 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 MULTISONIC (SUPER) CODE TSM?

MULTISONIC (SUPER) CODE TSM is a medical device that received FDA 510(k) clearance on 1977-06-24. The listed applicant is Qualitone. The 510(k) number is K771069.

When did MULTISONIC (SUPER) CODE TSM receive FDA 510(k) clearance?

MULTISONIC (SUPER) CODE TSM received FDA 510(k) clearance on 1977-06-24, under 510(k) number K771069.

Who is the listed applicant for MULTISONIC (SUPER) CODE TSM?

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 MULTISONIC (SUPER) CODE TSM?

The FDA product code for MULTISONIC (SUPER) CODE TSM 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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