Name: Predicase
Price: 199 USD

K-number	K984545
Device name	RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
Applicant	Philips Medical Systems North America, Inc.
Product code	IZI
Device class	Class II
Decision date	Feb 25, 1999
Decision	Substantially Equivalent
Regulation	892.1600

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Source

View the full FDA submission: accessdata.fda.gov

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RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS

Everything you need for a 510(k) submission. Nothing you don't.