External Counterpulsation System, Soulaire— 510(k) K202108

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..

Clearance details

Applicant: Vamed Medical Instrument Co., Ltd.
Product code: Code DRN
Advisory panel: Cardiovascular
Date received: 2020-07-30
Decision date: 2020-08-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Foshan, CN

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