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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2019-04-08 under 510(k) 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. The listed applicant is GE Medical Systems SCS. The 510(k) number is K183204.

When did Bone VCAR (BVCAR) receive FDA 510(k) clearance?

Bone VCAR (BVCAR) received FDA 510(k) clearance on 2019-04-08, under 510(k) number K183204.

Who is the listed applicant for Bone VCAR (BVCAR)?

The FDA 510(k) record lists GE Medical Systems SCS as the applicant. This does not by itself establish the device manufacturer.

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.

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