Bone VCAR (BVCAR)
K-Number: K183204 · 2019-04-08
ApplicantGE Medical Systems SCS
Decision Date2019-04-08
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Bone VCAR (BVCAR) is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2019-04-08 under approval number K183204. 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 Bone VCAR (BVCAR)?
Bone VCAR (BVCAR) is a medical device that received FDA 510(k) clearance on 2019-04-08. It is manufactured by GE Medical Systems SCS. The 510(k) number is K183204.
When was Bone VCAR (BVCAR) approved by the FDA?
Bone VCAR (BVCAR) received FDA 510(k) clearance on 2019-04-08, under approval number K183204.
What company makes Bone VCAR (BVCAR)?
Bone VCAR (BVCAR) is manufactured by GE Medical Systems SCS.
What is the FDA product code for Bone VCAR (BVCAR)?
The FDA product code for Bone VCAR (BVCAR) 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.