Vivo 60
K-Number: K160481 · 2016-11-09
ApplicantBreas Medical AB
Decision Date2016-11-09
Product CodeNOU
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Vivo 60 is a medical device manufactured by Breas Medical AB. It received FDA 510(k) clearance on 2016-11-09 under approval number K160481. The device is classified under product code NOU. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vivo 60?
Vivo 60 is a medical device that received FDA 510(k) clearance on 2016-11-09. It is manufactured by Breas Medical AB. The 510(k) number is K160481.
When was Vivo 60 approved by the FDA?
Vivo 60 received FDA 510(k) clearance on 2016-11-09, under approval number K160481.
What company makes Vivo 60?
Vivo 60 is manufactured by Breas Medical AB.
What is the FDA product code for Vivo 60?
The FDA product code for Vivo 60 is NOU.
Other Devices by Breas Medical AB
Related Devices (Code: NOU)
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.