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FDA 510(k)

EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH

K-Number: K903004 · 1990-11-15

ApplicantTeca, Inc.
Decision Date1990-11-15
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Teca, Inc.. It received FDA 510(k) clearance on 1990-11-15 under 510(k) number K903004. 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 EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH?

EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH is a medical device that received FDA 510(k) clearance on 1990-11-15. The listed applicant is Teca, Inc.. The 510(k) number is K903004.

When did EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH receive FDA 510(k) clearance?

EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH received FDA 510(k) clearance on 1990-11-15, under 510(k) number K903004.

Who is the listed applicant for EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH?

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 EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH?

The FDA product code for EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH is GWQ.

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Other records listing Teca, Inc. as applicant

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K962283EEG ELECTRODESK903731SAPPHIRE SERIES 1P, 1L, 2L, AND 2MEK896666P460, DG32 ELECTROENCEPHALOGRAPHK894889TECA NEUROMAPPER 386K894088TECA NEUROMAPPER 1620, BRAIN MAPPERK890881TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS

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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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