K-number	K232314
Device name	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
Applicant	FUJIFILM Healthcare Americas Corporation
Product code	FDS
Device class	Class II
Decision date	Sep 1, 2023
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)

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