FDA 510(k)

醫療監視器（32HR734S）

K 號：K241402 · 2024-08-12

決定日期2024-08-12

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Medical Monitor (32HR734S) is the device name listed in this FDA 510(k) record. The listed applicant is Lg Electronics.Inc. It received FDA 510(k) clearance on 2024-08-12 under 510(k) number K241402. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medical Monitor (32HR734S)?

Medical Monitor (32HR734S) is a medical device that received FDA 510(k) clearance on 2024-08-12. The listed applicant is Lg Electronics.Inc. The 510(k) number is K241402.

When did Medical Monitor (32HR734S) receive FDA 510(k) clearance?

Medical Monitor (32HR734S) received FDA 510(k) clearance on 2024-08-12, under 510(k) number K241402.

Who is the listed applicant for Medical Monitor (32HR734S)?

FDA 510(k) 記錄將 Lg Electronics.Inc 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Medical Monitor (32HR734S)?

The FDA product code for Medical Monitor (32HR734S) is GCJ.

其他以 Lg Electronics.Inc 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。

K261614LED LCD 螢幕 (OEV-271H)K261213醫療監視器（40HT513D）K251209醫療監視器（32HS710S）K243439醫療監視器（27HS714S）K233599X-Clever (ASHK100G)K240130醫療監視器（21HQ613D）

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相關器械（代碼：GCJ）

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE選擇系統Karl Storz SE & CO. KG K260972OEV-271MUH LCD 螢幕；OEV-321MUH LCD 螢幕；OEV-431MUH LCD 螢幕Sony Corporation K261139VereSee (VER150、VER200、VER151、VER201、VER200C 及 VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™（EZ Close Port Site Closing Device、EZ Close MAX Port Site Closing Device、EZ Close II Port Site Closing Device）Medical Impact K261614LED LCD 螢幕 (OEV-271H)Lg Electronics.Inc

官方來源

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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。