Procellera
K 號：K160783 · 2016-09-07
廣告
器材摘要
Procellera is the device name listed in this FDA 510(k) record. The listed applicant is Vomaris Innovations, Inc.. It received FDA 510(k) clearance on 2016-09-07 under 510(k) number K160783. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the Procellera?
Procellera is a medical device that received FDA 510(k) clearance on 2016-09-07. The listed applicant is Vomaris Innovations, Inc.. The 510(k) number is K160783.
When did Procellera receive FDA 510(k) clearance?
Procellera received FDA 510(k) clearance on 2016-09-07, under 510(k) number K160783.
Who is the listed applicant for Procellera?
The FDA 510(k) record lists Vomaris Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Procellera?
The FDA product code for Procellera is FRO. This falls under the Anesthesiology category.
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：FRO）
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。
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