Vivo 1, Vivo 2
K-Number: K240778 · 2024-12-13
ApplicantBreas Medical AB
Decision Date2024-12-13
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Vivo 1, Vivo 2 is a medical device manufactured by Breas Medical AB. It received FDA 510(k) clearance on 2024-12-13 under approval 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.
Frequently Asked Questions
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. It is manufactured by Breas Medical AB. The 510(k) number is K240778.
When was Vivo 1, Vivo 2 approved by the FDA?
Vivo 1, Vivo 2 received FDA 510(k) clearance on 2024-12-13, under approval number K240778.
What company makes Vivo 1, Vivo 2?
Vivo 1, Vivo 2 is manufactured by Breas Medical AB.
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.
Other Devices by Breas Medical AB
Related Devices (Code: MNS)
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.