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FDA 510(k)

TECA MODEL-10 ELECTROMYOGRAPH

K-Number: K802637 · 1980-11-26

ApplicantTeca, Inc.
Decision Date1980-11-26
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TECA MODEL-10 ELECTROMYOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Teca, Inc.. It received FDA 510(k) clearance on 1980-11-26 under 510(k) number K802637. 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 MODEL-10 ELECTROMYOGRAPH?

TECA MODEL-10 ELECTROMYOGRAPH is a medical device that received FDA 510(k) clearance on 1980-11-26. The listed applicant is Teca, Inc.. The 510(k) number is K802637.

When did TECA MODEL-10 ELECTROMYOGRAPH receive FDA 510(k) clearance?

TECA MODEL-10 ELECTROMYOGRAPH received FDA 510(k) clearance on 1980-11-26, under 510(k) number K802637.

Who is the listed applicant for TECA MODEL-10 ELECTROMYOGRAPH?

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 MODEL-10 ELECTROMYOGRAPH?

The FDA product code for TECA MODEL-10 ELECTROMYOGRAPH is IKN.

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Other records listing Teca, 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.

K962283EEG ELECTRODESK903731SAPPHIRE SERIES 1P, 1L, 2L, AND 2MEK903004EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPHK896666P460, DG32 ELECTROENCEPHALOGRAPHK894889TECA NEUROMAPPER 386K894088TECA NEUROMAPPER 1620, BRAIN MAPPER

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Related Devices (Code: 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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