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FDA 510(k)

Enhanced External Counter Pulsation Device Plus Omay-A

K-Number: K191955 · 2020-08-05

ApplicantOmay(Guangzhou)Med Technologies Co., Ltd.
Decision Date2020-08-05
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Enhanced External Counter Pulsation Device Plus Omay-A is the device name listed in this FDA 510(k) record. The listed applicant is Omay(Guangzhou)Med Technologies Co., Ltd.. It received FDA 510(k) clearance on 2020-08-05 under 510(k) number K191955. 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 Enhanced External Counter Pulsation Device Plus Omay-A?

Enhanced External Counter Pulsation Device Plus Omay-A is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is Omay(Guangzhou)Med Technologies Co., Ltd.. The 510(k) number is K191955.

When did Enhanced External Counter Pulsation Device Plus Omay-A receive FDA 510(k) clearance?

Enhanced External Counter Pulsation Device Plus Omay-A received FDA 510(k) clearance on 2020-08-05, under 510(k) number K191955.

Who is the listed applicant for Enhanced External Counter Pulsation Device Plus Omay-A?

The FDA 510(k) record lists Omay(Guangzhou)Med Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enhanced External Counter Pulsation Device Plus Omay-A?

The FDA product code for Enhanced External Counter Pulsation Device Plus Omay-A is DRN.

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.K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd.K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd.K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC

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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