Name: Predicase
Price: 199 USD

K-number	K023420
Device name	PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
Applicant	Medical Electronic Devices, Inc.
Product code	NFB
Device class	Class II
Decision date	Oct 25, 2002
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB

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