Name: Predicase
Price: 199 USD

K-number	K062268
Device name	MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03
Applicant	Philips Medical Systems North America Co.
Product code	DQA
Device class	Class II
Decision date	Oct 18, 2006
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03

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