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FDA 510(k)

External Counterpulsation System, Soulaire

K-Number: K202108 · 2020-08-28

ApplicantVamed Medical Instrument Co., Ltd.
Decision Date2020-08-28
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

External Counterpulsation System, Soulaire is a medical device manufactured by Vamed Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2020-08-28 under approval number K202108. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the External Counterpulsation System, Soulaire?

External Counterpulsation System, Soulaire is a medical device that received FDA 510(k) clearance on 2020-08-28. It is manufactured by Vamed Medical Instrument Co., Ltd.. The 510(k) number is K202108.

When was External Counterpulsation System, Soulaire approved by the FDA?

External Counterpulsation System, Soulaire received FDA 510(k) clearance on 2020-08-28, under approval number K202108.

What company makes External Counterpulsation System, Soulaire?

External Counterpulsation System, Soulaire is manufactured by Vamed Medical Instrument Co., Ltd..

What is the FDA product code for External Counterpulsation System, Soulaire?

The FDA product code for External Counterpulsation System, Soulaire is DRN.

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Other Devices by Vamed Medical Instrument Co., Ltd.

K190683External Counterpulsation System

Related Devices (Code: DRN)

K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd. K191955Enhanced External Counter Pulsation Device Plus Omay-AOmay(Guangzhou)Med Technologies Co., Ltd. K250756Pression Wave PRO External Counter-Pulsation SystemPression, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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