Repair Electro-Cap R1

• FDA 510(k) K112319 decided 27 Jan 2012 Active
• FDA GUDID UDI-DI 00811478012828 listed 23 Sep 2016 Listed

1. 27 Jan 2012 Cleared FDA 510(k) K112319
2. 23 Sep 2016 Listed FDA GUDID 00811478012828

Trade name

Repair Electro-Cap

Generic name

Analytical scalp lead

Model / Ref / Catalog

R1

Primary DI / UDI-DI

00811478012828

510(k) Number

K112319 ↗

FDA product code

GXY

GMDN term

Analytical scalp lead

Device class

Class II

Regulation number

882.1320

GUDID distribution status

In Commercial Distribution

Category: Analytical scalp lead

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• Neuro-Pulse System 2/CS2005 Np-SYS2

  Class II

  FDA 510(k) K112319 Active Cleared 27 Jan 2012 GUDID on market

• Deymed Cap-Small E1-Dey-Sm

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  FDA 510(k) K112319 Active Cleared 27 Jan 2012 GUDID on market

• Special Cap W/21 Electrodes Special Cap 1X

  Class II

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See all devices from Electro-Cap International Inc →