Operio
K-Number: K153498 · 2016-07-20
ApplicantToul Meditech AB
Decision Date2016-07-20
Product CodeORC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Operio is a medical device manufactured by Toul Meditech AB. It received FDA 510(k) clearance on 2016-07-20 under approval number K153498. The device is classified under product code ORC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Operio?
Operio is a medical device that received FDA 510(k) clearance on 2016-07-20. It is manufactured by Toul Meditech AB. The 510(k) number is K153498.
When was Operio approved by the FDA?
Operio received FDA 510(k) clearance on 2016-07-20, under approval number K153498.
What company makes Operio?
Operio is manufactured by Toul Meditech AB.
What is the FDA product code for Operio?
The FDA product code for Operio is ORC.
Other Devices by Toul Meditech AB
Related Devices (Code: ORC)
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.