FDA 510(k)

長頸鹿全能床護理站（CS1）；長頸鹿育嬰箱護理站（CS1）

K 號：K251663 · 2025-10-22

決定日期2025-10-22

產品代碼FMZ

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K251663. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)?

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K251663.

When did Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) receive FDA 510(k) clearance?

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) received FDA 510(k) clearance on 2025-10-22, under 510(k) number K251663.

Who is the listed applicant for Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)?

FDA 510(k) 記錄將 Datex-Ohmeda, 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 Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)?

The FDA product code for Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) is FMZ.

其他以 Datex-Ohmeda, 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。

K254036Novii+ 電子貼片系統 K260326Giraffe™ OmniBed™ 照護站（CS1）；Giraffe™ 培育箱照護站（CS1）K213867Carestation 750/750c K213551長頸鹿全能床護理站 CS1 K213553Giraffe Incubator Carestation CS1 K210384CARESCAPE R860

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相關器械（代碼：FMZ）

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。

K260326Giraffe™ OmniBed™ 照護站（CS1）；Giraffe™ 培育箱照護站（CS1）Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaA K243437mOm 精準培養箱 (ME1)Mom Incubators Limited K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K190494嬰兒培養箱Ningbo David Medical Device Co., Ltd.K182859Babyleo TN500Dragerwerk AG & CO Kgaa

官方來源

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