Name: Predicase
Price: 199 USD

K-number	K063783
Device name	PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
Applicant	Philips Medical Systems, Inc.
Product code	DQA
Device class	Class II
Decision date	Apr 27, 2007
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A

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