K-number	K160412
Device name	GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
Applicant	Instrumentation Laboratory CO
Product code	CHL
Device class	Class II
Decision date	Dec 14, 2016
Decision	Substantially Equivalent
Regulation	862.1120

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GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)

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