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FDA 510(k)

External Counterpulsation System

K-Number: K190683 · 2019-09-10

ApplicantVamed Medical Instrument Co., Ltd.
Decision Date2019-09-10
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

External Counterpulsation System is a medical device manufactured by Vamed Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2019-09-10 under approval number K190683. 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?

External Counterpulsation System is a medical device that received FDA 510(k) clearance on 2019-09-10. It is manufactured by Vamed Medical Instrument Co., Ltd.. The 510(k) number is K190683.

When was External Counterpulsation System approved by the FDA?

External Counterpulsation System received FDA 510(k) clearance on 2019-09-10, under approval number K190683.

What company makes External Counterpulsation System?

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

What is the FDA product code for External Counterpulsation System?

The FDA product code for External Counterpulsation System is DRN.

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Other Devices by Vamed Medical Instrument Co., Ltd.

K202108External Counterpulsation System, Soulaire

Related Devices (Code: DRN)

K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC K202108External Counterpulsation System, SoulaireVamed 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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