Evita V800, Evita V600
K 號：K222024 · 2023-05-16
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器材摘要
Evita V800, Evita V600 is the device name listed in this FDA 510(k) record. The listed applicant is Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K222024. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Evita V800, Evita V600?
Evita V800, Evita V600 is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K222024.
When did Evita V800, Evita V600 receive FDA 510(k) clearance?
Evita V800, Evita V600 received FDA 510(k) clearance on 2023-05-16, under 510(k) number K222024.
Who is the listed applicant for Evita V800, Evita V600?
The FDA 510(k) record lists Draegerwerk AG & CO Kgaa as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Evita V800, Evita V600?
The FDA product code for Evita V800, Evita V600 is CBK.
相關臨床試驗
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其他以 Draegerwerk AG & CO Kgaa 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。
相關器械（代碼：CBK）
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。
K253647Evita (V800)；Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus 多功能Iconic Solutions by Murcia, SLK251888VPAP兒童臉部口罩Hsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV醫院通氣全臉罩，適用單肢循環 – 尺寸A (ONIV117A)；F&P OptiNIV醫院通氣全臉罩，適用單肢循環 – 尺寸B (ONIV117B)；F&P OptiNIV醫院通氣全臉罩，適用單肢循環 – 尺寸C (ONIV117C)；F&P OptiNIV ONIV117-F醫院通氣全臉罩，可選配呼氣過濾器，適用單肢循環 - 尺寸A (ONIV117A-F)；F&P OptiNIV ONIV117-F醫院通氣全臉罩Fisher & Paykel Healthcare, Ltd.K243767SV600、SV800 呼吸器Shenzhen Mindray Bio-Medical Electronics 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。
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