Name: Predicase
Price: 199 USD

K-number	K081203
Device name	OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
Applicant	Philips Medizin Systeme Boeblingen GmbH
Product code	HGM
Device class	Class II
Decision date	May 28, 2008
Decision	Substantially Equivalent
Regulation	884.2740

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Source

View the full FDA submission: accessdata.fda.gov

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OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00

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