Bonvadis®
K-Number: K251093 · 2025-06-09
ApplicantOneness Biotech Co., Ltd.
Decision Date2025-06-09
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Bonvadis® is a medical device manufactured by Oneness Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-06-09 under approval number K251093. 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.
Frequently Asked Questions
What is the Bonvadis®?
Bonvadis® is a medical device that received FDA 510(k) clearance on 2025-06-09. It is manufactured by Oneness Biotech Co., Ltd.. The 510(k) number is K251093.
When was Bonvadis® approved by the FDA?
Bonvadis® received FDA 510(k) clearance on 2025-06-09, under approval number K251093.
What company makes Bonvadis®?
Bonvadis® is manufactured by Oneness Biotech Co., Ltd..
What is the FDA product code for Bonvadis®?
The FDA product code for Bonvadis® is FRO. This falls under the Anesthesiology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.