呼吸科技 Life2000™ 通氣系統
K 號：K170037 · 2017-08-11
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器材摘要
Breathe Technologies Life2000™ Ventilation System is the device name listed in this FDA 510(k) record. The listed applicant is Breathe Technologies. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K170037. 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 Breathe Technologies Life2000™ Ventilation System?
Breathe Technologies Life2000™ Ventilation System is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Breathe Technologies. The 510(k) number is K170037.
When did Breathe Technologies Life2000™ Ventilation System receive FDA 510(k) clearance?
Breathe Technologies Life2000™ Ventilation System received FDA 510(k) clearance on 2017-08-11, under 510(k) number K170037.
Who is the listed applicant for Breathe Technologies Life2000™ Ventilation System?
The FDA 510(k) record lists Breathe Technologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Breathe Technologies Life2000™ Ventilation System?
The FDA product code for Breathe Technologies Life2000™ Ventilation System is CBK.
相關臨床試驗
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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。
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官方來源
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