Vivo 1, Vivo 2
K 號：K240778 · 2024-12-13
廣告
器材摘要
Vivo 1, Vivo 2 is the device name listed in this FDA 510(k) record. The listed applicant is Breas Medical AB. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K240778. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the Vivo 1, Vivo 2?
Vivo 1, Vivo 2 is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is Breas Medical AB. The 510(k) number is K240778.
When did Vivo 1, Vivo 2 receive FDA 510(k) clearance?
Vivo 1, Vivo 2 received FDA 510(k) clearance on 2024-12-13, under 510(k) number K240778.
Who is the listed applicant for Vivo 1, Vivo 2?
The FDA 510(k) record lists Breas Medical AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vivo 1, Vivo 2?
The FDA product code for Vivo 1, Vivo 2 is MNS. This falls under the Neurology category.
其他以 Breas Medical AB 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：MNS）
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