Name: Predicase
Price: 199 USD

K-number	K191955
Device name	Enhanced External Counter Pulsation Device Plus Omay-A
Applicant	Omay(Guangzhou)Med Technologies Co., Ltd.
Product code	DRN
Device class	Class II
Decision date	Aug 5, 2020
Decision	Substantially Equivalent
Regulation	870.5225

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Source

View the full FDA submission: accessdata.fda.gov

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Enhanced External Counter Pulsation Device Plus Omay-A

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