K-number	K153483
Device name	Balloon controller PB-30
Applicant	Fujifilm Medical Systems U.S.A, Inc.
Product code	FDF
Device class	Class II
Decision date	Dec 15, 2015
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Balloon controller PB-30

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