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FDA 510(k)

DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS

K-Number: K890710 · 1989-03-14

ApplicantSomatics, Inc.
Decision Date1989-03-14
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS is the device name listed in this FDA 510(k) record. The listed applicant is Somatics, Inc.. It received FDA 510(k) clearance on 1989-03-14 under 510(k) number K890710. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS?

DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS is a medical device that received FDA 510(k) clearance on 1989-03-14. The listed applicant is Somatics, Inc.. The 510(k) number is K890710.

When did DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS receive FDA 510(k) clearance?

DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS received FDA 510(k) clearance on 1989-03-14, under 510(k) number K890710.

Who is the listed applicant for DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS?

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

What is the FDA product code for DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS?

The FDA product code for DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS is GXY.

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Other records listing Somatics, 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.

K992269VENTIL-A ORAL PROTECTORK945120THYMATRON 2000 ELECTROCONVULSIVE SYSTEMK890711DUAL GRAPH (TM) RECORDER-MONITORK882809THYMAPADK864181SOMATICS MOUTH GUARD (BITE BLOCK)K843923THYMATRON

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Related Devices (Code: GXY)

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.

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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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