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FDA 510(k)

TELSTAR PREWIRE SERIES

K-Number: K871731 · 1987-10-27

ApplicantTelstar Electronics, Inc.
Decision Date1987-10-27
Product CodeLRS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TELSTAR PREWIRE SERIES 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 1987-10-27 under 510(k) number K871731. The device is classified under product code LRS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELSTAR PREWIRE SERIES?

TELSTAR PREWIRE SERIES is a medical device that received FDA 510(k) clearance on 1987-10-27. The listed applicant is Telstar Electronics, Inc.. The 510(k) number is K871731.

When did TELSTAR PREWIRE SERIES receive FDA 510(k) clearance?

TELSTAR PREWIRE SERIES received FDA 510(k) clearance on 1987-10-27, under 510(k) number K871731.

Who is the listed applicant for TELSTAR PREWIRE SERIES?

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 PREWIRE SERIES?

The FDA product code for TELSTAR PREWIRE SERIES is LRS.

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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 AIDK873210TELSTAR MODEL PPK871520TELSTAR MODEL FS HEARING AID

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Related Devices (Code: LRS)

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.

K050654AMSINO I.V. START KITAmsino International, Inc.K001879INFUSION IV SETNirvi Intl. USAK963722IV START KITGrand Medical ProductsK951167EMS I.V. START KITEmergency Medical Supply, Inc.K950184B. BRAUN IV START KITSB. Braun of America, Inc.K944041PERSONAL HEARING SYSTEMResound Corp.

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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