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FDA 510(k)

TECA/MEDELEC AUDIOSTAR

K-Number: K863156 · 1987-02-03

ApplicantTeca, Inc.
Decision Date1987-02-03
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TECA/MEDELEC AUDIOSTAR is the device name listed in this FDA 510(k) record. The listed applicant is Teca, Inc.. It received FDA 510(k) clearance on 1987-02-03 under 510(k) number K863156. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECA/MEDELEC AUDIOSTAR?

TECA/MEDELEC AUDIOSTAR is a medical device that received FDA 510(k) clearance on 1987-02-03. The listed applicant is Teca, Inc.. The 510(k) number is K863156.

When did TECA/MEDELEC AUDIOSTAR receive FDA 510(k) clearance?

TECA/MEDELEC AUDIOSTAR received FDA 510(k) clearance on 1987-02-03, under 510(k) number K863156.

Who is the listed applicant for TECA/MEDELEC AUDIOSTAR?

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

What is the FDA product code for TECA/MEDELEC AUDIOSTAR?

The FDA product code for TECA/MEDELEC AUDIOSTAR is GWJ.

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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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