Name: Predicase
Price: 199 USD

K-number	K052377
Device name	PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.
Applicant	Philips Medizin Systeme Boeblingen GmbH
Product code	DQA
Device class	Class II
Decision date	Nov 17, 2005
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.

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