K-number	K231914
Device name	Nurochek-II System
Applicant	Headsafe Mfg Pty, Ltd.
Product code	PIW
Device class	Class II
Decision date	Dec 27, 2023
Decision	Substantially Equivalent
Regulation	882.1450

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View the full FDA submission: accessdata.fda.gov

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Nurochek-II System

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