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Disposable Eeg/Ekg Electrode, Cat. #eeds

FDA 510(k)

Class II (US FDA 510(k))

510(k) K890710

by Somatics, Inc.

Identifiers

510(k) Number
K890710 FDA 510(k)
FDA Product Code
GXY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1320 FDA 510(k)
Regulation Number
882.1320 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Disposable Eeg/Ekg Electrode, Cat. #eeds by Somatics, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Somatics, Inc.

Sources (1)

  • FDA 510(k) K890710 24 fields · synced Jun 19, 2026