K-number	K982568
Device name	BLADDERMANAGER PCI 5000 MODEL 1002
Applicant	Diagnostic Ultrasound Corp.
Product code	ITX
Device class	Class II
Decision date	Jan 25, 1999
Decision	Substantially Equivalent
Regulation	892.1570

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View the full FDA submission: accessdata.fda.gov

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BLADDERMANAGER PCI 5000 MODEL 1002

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