FDA 510(k)

医疗设备名称：medi气动压缩系统（PCS）-Genius（型号652）

K号: K221654 · 2022-07-07

决定日期2022-07-07

产品代码JOW

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

medi pneumatic compression system (pcs)-genius (Model 652) is the device name listed in this FDA 510(k) record. The listed applicant is Medi USA, LP. It received FDA 510(k) clearance on 2022-07-07 under 510(k) number K221654. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the medi pneumatic compression system (pcs)-genius (Model 652)?

medi pneumatic compression system (pcs)-genius (Model 652) is a medical device that received FDA 510(k) clearance on 2022-07-07. The listed applicant is Medi USA, LP. The 510(k) number is K221654.

When did medi pneumatic compression system (pcs)-genius (Model 652) receive FDA 510(k) clearance?

medi pneumatic compression system (pcs)-genius (Model 652) received FDA 510(k) clearance on 2022-07-07, under 510(k) number K221654.

Who is the listed applicant for medi pneumatic compression system (pcs)-genius (Model 652)?

The FDA 510(k) record lists Medi USA, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for medi pneumatic compression system (pcs)-genius (Model 652)?

The FDA product code for medi pneumatic compression system (pcs)-genius (Model 652) is JOW.

列明Medi USA, LP为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K183631医疗设备名称：medi气动压缩系统（PCS）- Brio（型号651）

官方来源

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