External Counterpulsation System— 510(k) K190683

Name: FDA 510(k) clearance K190683
Creator: U.S. Food and Drug Administration
Published: 2019-09-10

Substantially Equivalent

Vamed Medical Instrument Co., Ltd.

FDA 510(k) clearance K190683 for External Counterpulsation System, Substantially Equivalent on 2019-09-10. Applicant: Vamed Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Vamed Medical Instrument Co., Ltd.
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2019-03-18
Decision date: 2019-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, CN

Download summary PDF View on FDA.gov ↗

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