FDA 510(k)

CIRCUL8 Luxe 靜脈血栓預防裝置

K 號：K211235 · 2021-09-08

決定日期2021-09-08

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

CIRCUL8 Luxe DVT Prevention Device is the device name listed in this FDA 510(k) record. The listed applicant is Ortho8, Inc.. It received FDA 510(k) clearance on 2021-09-08 under 510(k) number K211235. 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 CIRCUL8 Luxe DVT Prevention Device?

CIRCUL8 Luxe DVT Prevention Device is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is Ortho8, Inc.. The 510(k) number is K211235.

When did CIRCUL8 Luxe DVT Prevention Device receive FDA 510(k) clearance?

CIRCUL8 Luxe DVT Prevention Device received FDA 510(k) clearance on 2021-09-08, under 510(k) number K211235.

Who is the listed applicant for CIRCUL8 Luxe DVT Prevention Device?

The FDA 510(k) record lists Ortho8, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CIRCUL8 Luxe DVT Prevention Device?

The FDA product code for CIRCUL8 Luxe DVT Prevention Device is JOW.

其他以 Ortho8, Inc. 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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