FDA 510(k)

熱狗加熱褥墊 + 返回電極

K 號：K230866 · 2023-06-29

申請人Augustine Temperature Management, LLC

決定日期2023-06-29

產品代碼DWJ

諮詢委員會履歷

決定相當於

器材摘要

HotDog Warming Mattress + Return Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Augustine Temperature Management, LLC. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K230866. 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 HotDog Warming Mattress + Return Electrode?

HotDog Warming Mattress + Return Electrode is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is Augustine Temperature Management, LLC. The 510(k) number is K230866.

When did HotDog Warming Mattress + Return Electrode receive FDA 510(k) clearance?

HotDog Warming Mattress + Return Electrode received FDA 510(k) clearance on 2023-06-29, under 510(k) number K230866.

Who is the listed applicant for HotDog Warming Mattress + Return Electrode?

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

What is the FDA product code for HotDog Warming Mattress + Return Electrode?

The FDA product code for HotDog Warming Mattress + Return Electrode is DWJ.

其他以 Augustine Temperature Management, LLC 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。

K232627熱狗加熱褥墊 + 返回電極 K210727熱狗加熱褥墊 + 返回電極

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

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。