Enhanced External Counter Pulsation Device Plus Omay-A— 510(k) K191955

Name: FDA 510(k) clearance K191955
Creator: U.S. Food and Drug Administration
Published: 2020-08-05

Substantially Equivalent

Omay(Guangzhou)Med Technologies Co., Ltd.

FDA 510(k) clearance K191955 for Enhanced External Counter Pulsation Device Plus Omay-A, Substantially Equivalent on 2020-08-05. Applicant: Omay(Guangzhou)Med Technologies Co., Ltd.. Device class: 2.

Clearance details

Applicant: Omay(Guangzhou)Med Technologies Co., Ltd.
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2019-07-22
Decision date: 2020-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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