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FDA 510(k)

TELSTAR MODEL 0/3 HEARING AID

K-Number: K871519 · 1987-05-19

ApplicantTelstar Electronics, Inc.
Decision Date1987-05-19
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TELSTAR MODEL 0/3 HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Telstar Electronics, Inc.. It received FDA 510(k) clearance on 1987-05-19 under 510(k) number K871519. 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 TELSTAR MODEL 0/3 HEARING AID?

TELSTAR MODEL 0/3 HEARING AID is a medical device that received FDA 510(k) clearance on 1987-05-19. The listed applicant is Telstar Electronics, Inc.. The 510(k) number is K871519.

When did TELSTAR MODEL 0/3 HEARING AID receive FDA 510(k) clearance?

TELSTAR MODEL 0/3 HEARING AID received FDA 510(k) clearance on 1987-05-19, under 510(k) number K871519.

Who is the listed applicant for TELSTAR MODEL 0/3 HEARING AID?

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

What is the FDA product code for TELSTAR MODEL 0/3 HEARING AID?

The FDA product code for TELSTAR MODEL 0/3 HEARING AID is ESD.

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Other records listing Telstar Electronics, 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.

K892458TELSTAR MODEL F ITE HEARING AIDK892457TELSTAR MODEL 1/3 ITE HEARING AIDK892459TELSTAR MODEL C ITE HEARING AIDK892460TELSTAR MODEL PP ITE HEARING AIDK871731TELSTAR PREWIRE SERIESK873210TELSTAR MODEL PP

View all 11 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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