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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 the device name listed in this FDA 510(k) record. The listed applicant is Vamed Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2020-08-28 under 510(k) 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. The listed applicant is Vamed Medical Instrument Co., Ltd.. The 510(k) number is K202108.

When did External Counterpulsation System, Soulaire receive FDA 510(k) clearance?

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

Who is the listed applicant for External Counterpulsation System, Soulaire?

The FDA 510(k) record lists Vamed Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Vamed Medical Instrument Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190683External Counterpulsation System

Related Devices (Code: DRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

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

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