K-number	K971365
Device name	PHILIPS INTEGRIS H5000
Applicant	Philips Medical Systems North America, Inc.
Product code	IZI
Device class	Class II
Decision date	May 14, 1997
Decision	Substantially Equivalent
Regulation	892.1600

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View the full FDA submission: accessdata.fda.gov

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PHILIPS INTEGRIS H5000

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