Name: Predicase
Price: 199 USD

K-number	K102464
Device name	QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
Applicant	Maquet Cardiopulmonary, AG
Product code	DTZ
Device class	Class II
Decision date	Mar 4, 2011
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING

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