Name: Predicase
Price: 199 USD

K-number	K014301
Device name	MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
Applicant	Merits Health Products Co., Ltd.
Product code	CAW
Device class	Class II
Decision date	Feb 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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MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS

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