FDA 510(k)

美林舒適溫度病人加溫系統

K 號：K231211 · 2023-12-01

決定日期2023-12-01

產品代碼DWJ

諮詢委員會履歷

決定相當於

器材摘要

Medline ComfortTemp Patient Warming System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K231211. 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 Medline ComfortTemp Patient Warming System?

Medline ComfortTemp Patient Warming System is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Medline Industries, LP. The 510(k) number is K231211.

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

Medline ComfortTemp Patient Warming System received FDA 510(k) clearance on 2023-12-01, under 510(k) number K231211.

Who is the listed applicant for Medline ComfortTemp Patient Warming System?

FDA 510(k) 記錄中將 Medline Industries, LP 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Medline ComfortTemp Patient Warming System?

The FDA product code for Medline ComfortTemp Patient Warming System is DWJ.

其他以 Medline Industries, LP 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。

K253526NAMIC 扩張器及套管 K254287Medline可重用血壓袖帶 K253322Hudson RCI®嬰兒乾燥技術TM呼吸回路 (HUD99060 / 乾燥技術配78英寸嬰兒回路，HUD99060KIT / 乾燥技術配78英寸嬰兒回路套件，HUD99001KIT / 单臂嬰兒回路乾燥技術套件，HUD99009KIT / 乾燥技術配60英寸嬰兒回路套件，HUD99018KIT / 乾燥技術配44英寸嬰兒回路套件，HUD870NKIT / 乾燥技術嬰兒配件袋，HUD1631 / 嬰兒Y型接頭配轉動環)K251687康尼格貝爾環切夾 K253070Namic 放射臂帶，23 公分（DYNJRADBAND）；Namic 放射臂帶，26 公分（DYNJRADBANDL）K250345美林袋式分酒器

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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。

K262089一次性加熱毯Hangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® 加熱系統The Surgical Company International B.V., doing business as TSC Life K260278ThermAffyx™ 病患安全系統Stihler Electronic GmbH K260903熱粉紅墊加熱系統Xodus Medical, Inc.K252861加熱系統Hangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun 溫度管理系統 (型號 5000)Medivance, Inc.

官方來源

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