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FDA 510(k)

可壓縮肢體及循環治療系統

K 號:K200660 · 2021-03-08

決定日期2021-03-08
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Compressible Limb and Circulation Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Wonjin Mulsan Co., Ltd.. It received FDA 510(k) clearance on 2021-03-08 under 510(k) number K200660. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Compressible Limb and Circulation Therapy System?

Compressible Limb and Circulation Therapy System is a medical device that received FDA 510(k) clearance on 2021-03-08. The listed applicant is Wonjin Mulsan Co., Ltd.. The 510(k) number is K200660.

When did Compressible Limb and Circulation Therapy System receive FDA 510(k) clearance?

Compressible Limb and Circulation Therapy System received FDA 510(k) clearance on 2021-03-08, under 510(k) number K200660.

Who is the listed applicant for Compressible Limb and Circulation Therapy System?

The FDA 510(k) record lists Wonjin Mulsan Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Compressible Limb and Circulation Therapy System?

The FDA product code for Compressible Limb and Circulation Therapy System is IRP.

相關臨床試驗

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其他以 Wonjin Mulsan 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。

相關器械(代碼:IRP)

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。

官方來源

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