Name: Predicase
Price: 199 USD

K-number	K130439
Device name	EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
Applicant	Chongqing Psk Sci-Tech Development Co., Ltd.
Product code	DRN
Device class	Class II
Decision date	Dec 12, 2013
Decision	Substantially Equivalent
Regulation	870.5225

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Source

View the full FDA submission: accessdata.fda.gov

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EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING

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