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FDA 510(k)

TECA #TE 8

K-Number: K812715 · 1981-10-13

ApplicantTeca, Inc.
Decision Date1981-10-13
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TECA #TE 8 is the device name listed in this FDA 510(k) record. The listed applicant is Teca, Inc.. It received FDA 510(k) clearance on 1981-10-13 under 510(k) number K812715. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECA #TE 8?

TECA #TE 8 is a medical device that received FDA 510(k) clearance on 1981-10-13. The listed applicant is Teca, Inc.. The 510(k) number is K812715.

When did TECA #TE 8 receive FDA 510(k) clearance?

TECA #TE 8 received FDA 510(k) clearance on 1981-10-13, under 510(k) number K812715.

Who is the listed applicant for TECA #TE 8?

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 #TE 8?

The FDA product code for TECA #TE 8 is IKN.

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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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