K-number	K103604
Device name	ISA CO2, ISA AX+, ISA OR+
Applicant	Phasein AB
Product code	CCK
Device class	Class II
Decision date	Apr 6, 2011
Decision	Substantially Equivalent
Regulation	868.1400

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Source

View the full FDA submission: accessdata.fda.gov

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ISA CO2, ISA AX+, ISA OR+

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