CorSens
K-Number: K160656 · 2016-11-21
ApplicantCorsens Medical , Ltd.
Decision Date2016-11-21
Product CodeDXR
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CorSens is a medical device manufactured by Corsens Medical , Ltd.. It received FDA 510(k) clearance on 2016-11-21 under approval number K160656. The device is classified under product code DXR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CorSens?
CorSens is a medical device that received FDA 510(k) clearance on 2016-11-21. It is manufactured by Corsens Medical , Ltd.. The 510(k) number is K160656.
When was CorSens approved by the FDA?
CorSens received FDA 510(k) clearance on 2016-11-21, under approval number K160656.
What company makes CorSens?
CorSens is manufactured by Corsens Medical , Ltd..
What is the FDA product code for CorSens?
The FDA product code for CorSens is DXR.
Related Devices (Code: DXR)
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.