Name: Predicase
Price: 199 USD

K-number	K083559
Device name	YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B
Applicant	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Product code	CAW
Device class	Class II
Decision date	Sep 4, 2009
Decision	Substantially Equivalent
Regulation	868.5440

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Source

View the full FDA submission: accessdata.fda.gov

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YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B

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