Name: Predicase
Price: 199 USD

K-number	K201916
Device name	Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator
Applicant	Sorin Group Italia S.R.L.
Product code	DTZ
Device class	Class II
Decision date	Aug 13, 2020
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator

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