Hepatic VCAR
K-Number: K193281 · 2020-03-20
ApplicantGE Medical Systems SCS
Decision Date2020-03-20
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Hepatic VCAR is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2020-03-20 under approval number K193281. 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 Hepatic VCAR?
Hepatic VCAR is a medical device that received FDA 510(k) clearance on 2020-03-20. It is manufactured by GE Medical Systems SCS. The 510(k) number is K193281.
When was Hepatic VCAR approved by the FDA?
Hepatic VCAR received FDA 510(k) clearance on 2020-03-20, under approval number K193281.
What company makes Hepatic VCAR?
Hepatic VCAR is manufactured by GE Medical Systems SCS.
What is the FDA product code for Hepatic VCAR?
The FDA product code for Hepatic 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.