K-number	K161860
Device name	TG-970P CO2 Sensor Kit
Applicant	Nihon Kohden Corporation
Product code	CCK
Device class	Class II
Decision date	Feb 24, 2017
Decision	Substantially Equivalent
Regulation	868.1400

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Source

View the full FDA submission: accessdata.fda.gov

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TG-970P CO2 Sensor Kit

Everything you need for a 510(k) submission. Nothing you don't.