CORE12 C18006

• FDA 510(k) K103706 decided 24 Aug 2011 Active
• FDA GUDID UDI-DI 00853512007001 listed 27 Mar 2018 Listed

1. 24 Aug 2011 Cleared FDA 510(k) K103706
2. 27 Mar 2018 Listed FDA GUDID 00853512007001

Trade name

CORE12

Generic name

Telemetric electrocardiographic ambulatory recorder

Model / reference

C18006

Primary DI / UDI-DI

00853512007001

510(k) Number

K103706 ↗

FDA product code

DSI

GMDN term

Telemetric electrocardiographic ambulatory recorder

Device class

Class II

Regulation number

870.1025

GUDID distribution status

In Commercial Distribution

Category: Telemetric electrocardiographic ambulatory recorder

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See all devices from Applied Cardiac Systems, Inc. →