FDA 510(k)

B&J DVT 腿部/大腿服装，801/830系列型号

K号: K201532 · 2020-09-19

决定日期2020-09-19

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

B&J DVT Calf/Thigh Garments, Models 801/830 Series is the device name listed in this FDA 510(k) record. The listed applicant is B&J Manufacturing , Ltd.. It received FDA 510(k) clearance on 2020-09-19 under 510(k) number K201532. 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 B&J DVT Calf/Thigh Garments, Models 801/830 Series?

B&J DVT Calf/Thigh Garments, Models 801/830 Series is a medical device that received FDA 510(k) clearance on 2020-09-19. The listed applicant is B&J Manufacturing , Ltd.. The 510(k) number is K201532.

When did B&J DVT Calf/Thigh Garments, Models 801/830 Series receive FDA 510(k) clearance?

B&J DVT Calf/Thigh Garments, Models 801/830 Series received FDA 510(k) clearance on 2020-09-19, under 510(k) number K201532.

Who is the listed applicant for B&J DVT Calf/Thigh Garments, Models 801/830 Series?

The FDA 510(k) record lists B&J Manufacturing , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B&J DVT Calf/Thigh Garments, Models 801/830 Series?

The FDA product code for B&J DVT Calf/Thigh Garments, Models 801/830 Series is JOW.

列明B&J Manufacturing , Ltd.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。

K201547B&J DVT 足部服装，820系列型号 K200568B&J MHP800 深静脉血栓（DVT）预防系统 K200154B&J DVT 压缩设备 MHH800/MHH800SQ

官方来源

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