FDA 510(k)

B&J DVT足部衣物，820系列

K 號：K201547 · 2020-09-18

決定日期2020-09-18

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

B&J DVT Foot Garments, Models 820 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 2020-09-18 under 510(k) number K201547. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the B&J DVT Foot Garments, Models 820 Series?

B&J DVT Foot Garments, Models 820 Series is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is B&J Manufacturing , Ltd.. The 510(k) number is K201547.

When did B&J DVT Foot Garments, Models 820 Series receive FDA 510(k) clearance?

B&J DVT Foot Garments, Models 820 Series received FDA 510(k) clearance on 2020-09-18, under 510(k) number K201547.

Who is the listed applicant for B&J DVT Foot Garments, Models 820 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 Foot Garments, Models 820 Series?

The FDA product code for B&J DVT Foot Garments, Models 820 Series is JOW.

其他以 B&J Manufacturing , Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K201532B&J DVT 膝蓋/大腿衣襪，型號 801/830 系列 K200568B&J MHP800深部静脈血栓形成（DVT）預防系統 K200154B&J DVT 压力設備 MHH800/MHH800SQ

相關器械（代碼：JOW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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