K-number	K202050
Device name	Cranial 4Pi Immobilization
Applicant	Brainlab AG
Product code	IYE
Device class	Class II
Decision date	Aug 19, 2020
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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Cranial 4Pi Immobilization

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