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FDA 510(k)

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 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 2016-01-20 under 510(k) 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. The listed applicant is GE Medical Systems SCS. The 510(k) number is K152584.

When did Stroke VCAR receive FDA 510(k) clearance?

Stroke VCAR received FDA 510(k) clearance on 2016-01-20, under 510(k) number K152584.

Who is the listed applicant for Stroke VCAR?

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 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.

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