FDA 510(k)

SyneCare 1100 深部静脈血栓予防治療システム

K番号: K211937 · 2021-11-18

申請者Jiangsu Synecoun Medical Technology Co., Ltd.

決定日2021-11-18

製品コードJOW

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- **政策：medical-regulatory-v1** --- [ここに原文が記載されています] --- **会社名/製品名**：[ここに会社名または製品名が記載されています] **FDA**：食品医薬品局 **510(k)**：510(k)届出 **PMA**：プレマーケティング評価届出 **NCT**：臨床試験登録番号 **PMID**：PubMed ID **識別子**：[ここに識別子が記載されています] **URL**：[ここにURLが記載されています]

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてJiangsu Synecoun Medical Technology Co., Ltd.を記載するその他の記録

K203310SyneCare 1000 深部静脈血栓予防治療システム

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