External Counterpulsation System, Soulaire— 510(k) K202108

Name: FDA 510(k) clearance K202108
Creator: U.S. Food and Drug Administration
Published: 2020-08-28

Substantially Equivalent

Vamed Medical Instrument Co., Ltd.

FDA 510(k) clearance K202108 for External Counterpulsation System, Soulaire, Substantially Equivalent on 2020-08-28. 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: 2020-07-30
Decision date: 2020-08-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Foshan, CN

Download summary PDF View on FDA.gov ↗

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