長頸鹿全能床護理站 CS1
K 號：K152814 · 2016-03-17
廣告
決定日期2016-03-17
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 is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company. It received FDA 510(k) clearance on 2016-03-17 under 510(k) number K152814. 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 OmniBed Carestation CS1 is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company. The 510(k) number is K152814.
When did Giraffe OmniBed Carestation CS1 receive FDA 510(k) clearance?
Giraffe OmniBed Carestation CS1 received FDA 510(k) clearance on 2016-03-17, under 510(k) number K152814.
Who is the listed applicant for Giraffe OmniBed Carestation CS1?
The FDA 510(k) record lists Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Giraffe OmniBed Carestation CS1?
The FDA product code for Giraffe OmniBed Carestation CS1 is FMZ.
相關臨床試驗
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。
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. KGaAK251663長頸鹿全能床護理站（CS1）；長頸鹿育嬰箱護理站（CS1）Datex-Ohmeda, Inc.K243437mOm 精準培養箱 (ME1)Mom Incubators LimitedK213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K190494嬰兒培養箱Ningbo David Medical Device Co., Ltd.
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。
廣告