Bonvadis®
K 號：K261638 · 2026-06-17
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器材摘要
Bonvadis® is the device name listed in this FDA 510(k) record. The listed applicant is Oneness Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K261638. 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 Bonvadis®?
Bonvadis® is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Oneness Biotech Co., Ltd.. The 510(k) number is K261638.
When did Bonvadis® receive FDA 510(k) clearance?
Bonvadis® received FDA 510(k) clearance on 2026-06-17, under 510(k) number K261638.
Who is the listed applicant for Bonvadis®?
The FDA 510(k) record lists Oneness Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bonvadis®?
The FDA product code for Bonvadis® is FRO. This falls under the Anesthesiology category.
相關臨床試驗
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其他以 Oneness Biotech Co., Ltd. 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：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。
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