Name: Predicase
Price: 199 USD

K-number	K082655
Device name	ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106
Applicant	Envitec-Wismar GmbH
Product code	CCL
Device class	Class II
Decision date	Nov 25, 2008
Decision	Substantially Equivalent
Regulation	868.1720

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Source

View the full FDA submission: accessdata.fda.gov

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ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106

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