BIASURGE 高級外科解決方案
K 號：K223377 · 2023-03-30
廣告
器材摘要
BIASURGE Advanced Surgical Solution is the device name listed in this FDA 510(k) record. The listed applicant is Rochal Technologies, LLC. It received FDA 510(k) clearance on 2023-03-30 under 510(k) number K223377. 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 BIASURGE Advanced Surgical Solution?
BIASURGE Advanced Surgical Solution is a medical device that received FDA 510(k) clearance on 2023-03-30. The listed applicant is Rochal Technologies, LLC. The 510(k) number is K223377.
When did BIASURGE Advanced Surgical Solution receive FDA 510(k) clearance?
BIASURGE Advanced Surgical Solution received FDA 510(k) clearance on 2023-03-30, under 510(k) number K223377.
Who is the listed applicant for BIASURGE Advanced Surgical Solution?
The FDA 510(k) record lists Rochal Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BIASURGE Advanced Surgical Solution?
The FDA product code for BIASURGE Advanced Surgical Solution 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