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FDA 510(k)

TELESONIC ARCON & SOUNDEX ASP 101

K-Number: K802597 · 1980-11-12

ApplicantTelesonic, Inc.
Decision Date1980-11-12
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TELESONIC ARCON & SOUNDEX ASP 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 1980-11-12 under 510(k) number K802597. 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 ARCON & SOUNDEX ASP 101?

TELESONIC ARCON & SOUNDEX ASP 101 is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Telesonic, Inc.. The 510(k) number is K802597.

When did TELESONIC ARCON & SOUNDEX ASP 101 receive FDA 510(k) clearance?

TELESONIC ARCON & SOUNDEX ASP 101 received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802597.

Who is the listed applicant for TELESONIC ARCON & SOUNDEX ASP 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 ARCON & SOUNDEX ASP 101?

The FDA product code for TELESONIC ARCON & SOUNDEX ASP 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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