Name: Predicase
Price: 199 USD

K-number	K022684
Device name	PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)
Applicant	Essex Cryogenics of Missouri, Inc.
Product code	CAW
Device class	Class II
Decision date	Sep 11, 2002
Decision	Substantially Equivalent
Regulation	868.5440

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Source

View the full FDA submission: accessdata.fda.gov

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PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)

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