Stroke VCAR
K-Number: K152584 · 2016-01-20
ApplicantGE Medical Systems SCS
Decision Date2016-01-20
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Stroke VCAR is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2016-01-20 under approval number K152584. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Stroke VCAR?
Stroke VCAR is a medical device that received FDA 510(k) clearance on 2016-01-20. It is manufactured by GE Medical Systems SCS. The 510(k) number is K152584.
When was Stroke VCAR approved by the FDA?
Stroke VCAR received FDA 510(k) clearance on 2016-01-20, under approval number K152584.
What company makes Stroke VCAR?
Stroke VCAR is manufactured by GE Medical Systems SCS.
What is the FDA product code for Stroke VCAR?
The FDA product code for Stroke VCAR is JAK.
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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.