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FDA 510(k)

TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH

K-Number: K863749 · 1986-10-06

ApplicantTeca, Inc.
Decision Date1986-10-06
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Teca, Inc.. It received FDA 510(k) clearance on 1986-10-06 under 510(k) number K863749. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH?

TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH is a medical device that received FDA 510(k) clearance on 1986-10-06. The listed applicant is Teca, Inc.. The 510(k) number is K863749.

When did TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH receive FDA 510(k) clearance?

TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH received FDA 510(k) clearance on 1986-10-06, under 510(k) number K863749.

Who is the listed applicant for TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH?

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/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH?

The FDA product code for TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH is GWQ.

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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: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, 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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