艾索萊特8000加
K 號：K172154 · 2018-04-19
廣告
決定日期2018-04-19
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
Isolette 8000 plus is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Sytems, Inc.. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K172154. 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 Isolette 8000 plus?
Isolette 8000 plus is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Draeger Medical Sytems, Inc.. The 510(k) number is K172154.
When did Isolette 8000 plus receive FDA 510(k) clearance?
Isolette 8000 plus received FDA 510(k) clearance on 2018-04-19, under 510(k) number K172154.
Who is the listed applicant for Isolette 8000 plus?
The FDA 510(k) record lists Draeger Medical Sytems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Isolette 8000 plus?
The FDA product code for Isolette 8000 plus 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