FDA 510(k)

Enhanced External Counter Pulsation Device Plus Omay-A

K号: K191955 · 2020-08-05

申请人Omay(Guangzhou)Med Technologies Co., Ltd.

决定日期2020-08-05

产品代码DRN

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

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.

常见问题

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.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

Enhanced External Counter Pulsation Device Plus Omay-A

器械摘要

常见问题

相关临床试验

相关器械（代码：DRN）

官方来源