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CareFusion 209 Inc.

4 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part Number: recall (Z-0799-2012)CareFusion 209 Inc.2012-01-26
Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 Product Usage: The recall (Z-0800-2012)CareFusion 209 Inc.2012-01-26
Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 68 recall (Z-0801-2012)CareFusion 209 Inc.2012-01-26
NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: T recall (Z-0737-2012)CareFusion 209 Inc.2012-01-13

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