FDA 510(k)

小泡沫套件、中泡沫套件、大泡沫套件、超大泡沫套件

K 號：K211571 · 2022-05-31

申請人Zhejiang Longterm Medical Technology Co., Ltd.

決定日期2022-05-31

產品代碼OMP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K211571. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K211571.

When did Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit receive FDA 510(k) clearance?

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit received FDA 510(k) clearance on 2022-05-31, under 510(k) number K211571.

Who is the listed applicant for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

FDA 510(k) 記錄將浙江長期醫療技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

The FDA product code for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is OMP.

其他以 Zhejiang Longterm Medical Technology Co., 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。

K254246LT抗細菌泡沫銀膠布 K202823Innomed NPWT矽膠泡沫敷料 K192478LT抗細菌藻鹼銀膠布 K182458長期NPWT泡沫敷料套件

相關器械（代碼：OMP）

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。

K261338RENASYS DYNAFLOW 套件（66807741）Smith & Nephew Medical, Ltd.K253263ConvaVAC™ 負壓傷口治療系統Convatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 內容器 500-mL (CPC-500)Cork Medical K254019傷口基因NPWT系統Bechtel Medical, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。