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FDA 510(k)

NOVA病人加溫系統

K 號:K203085 · 2020-11-12

決定日期2020-11-12
產品代碼DWJ
諮詢委員會履歷
決定相當於

器材摘要

NOVA Patient Warming System is the device name listed in this FDA 510(k) record. The listed applicant is Encompass Group, LLC. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K203085. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NOVA Patient Warming System?

NOVA Patient Warming System is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is Encompass Group, LLC. The 510(k) number is K203085.

When did NOVA Patient Warming System receive FDA 510(k) clearance?

NOVA Patient Warming System received FDA 510(k) clearance on 2020-11-12, under 510(k) number K203085.

Who is the listed applicant for NOVA Patient Warming System?

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

What is the FDA product code for NOVA Patient Warming System?

The FDA product code for NOVA Patient Warming System is DWJ.

相關臨床試驗

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相關器械(代碼:DWJ)

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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