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FDA 510(k)

TELESONIC, SOUNDEX & GENERIC V-101

K-Number: K801066 · 1980-05-28

ApplicantTelesonic, Inc.
Decision Date1980-05-28
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TELESONIC, SOUNDEX & GENERIC V-101 is the device name listed in this FDA 510(k) record. The listed applicant is Telesonic, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K801066. 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 TELESONIC, SOUNDEX & GENERIC V-101?

TELESONIC, SOUNDEX & GENERIC V-101 is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Telesonic, Inc.. The 510(k) number is K801066.

When did TELESONIC, SOUNDEX & GENERIC V-101 receive FDA 510(k) clearance?

TELESONIC, SOUNDEX & GENERIC V-101 received FDA 510(k) clearance on 1980-05-28, under 510(k) number K801066.

Who is the listed applicant for TELESONIC, SOUNDEX & GENERIC V-101?

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

What is the FDA product code for TELESONIC, SOUNDEX & GENERIC V-101?

The FDA product code for TELESONIC, SOUNDEX & GENERIC V-101 is ESD.

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Other records listing Telesonic, 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.

K872606TELESONIC BODY STIMULATORK813330POST-AURICULAR HEARING AID MODEL S-101K813329POST-AURICULAR HEARING AID MODEL P-101K813316CUSTOM-IN-THE-EAR HEARING AIDK813344POST-AURICULAR HEARING AID MODEL ASP-103K811031TELESONIC & ARCON

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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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