K-number	K123043
Device name	IRMA C02 MODEL 200101; IRMA AX 200601
Applicant	Phasein AB
Product code	CCK
Device class	Class II
Decision date	Oct 25, 2012
Decision	Substantially Equivalent
Regulation	868.1400

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View the full FDA submission: accessdata.fda.gov

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IRMA C02 MODEL 200101; IRMA AX 200601

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