FDA 510(k)

SyneCare 1100 深部静脈血栓預防治療系統

K 號：K211937 · 2021-11-18

申請人Jiangsu Synecoun Medical Technology Co., Ltd.

決定日期2021-11-18

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Synecoun Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K211937. 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 SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System?

SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Jiangsu Synecoun Medical Technology Co., Ltd.. The 510(k) number is K211937.

When did SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System receive FDA 510(k) clearance?

SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System received FDA 510(k) clearance on 2021-11-18, under 510(k) number K211937.

Who is the listed applicant for SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System?

The FDA 510(k) record lists Jiangsu Synecoun Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System?

The FDA product code for SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is JOW.

其他以 Jiangsu Synecoun Medical Technology Co., Ltd. 為申請人之記錄

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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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