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FDA 510(k)

CT PERFUSION 2

K-Number: K010042 · 2001-01-30

ApplicantGeneral Electric Co.
Decision Date2001-01-30
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT PERFUSION 2 is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 2001-01-30 under 510(k) number K010042. 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 CT PERFUSION 2?

CT PERFUSION 2 is a medical device that received FDA 510(k) clearance on 2001-01-30. The listed applicant is General Electric Co.. The 510(k) number is K010042.

When did CT PERFUSION 2 receive FDA 510(k) clearance?

CT PERFUSION 2 received FDA 510(k) clearance on 2001-01-30, under 510(k) number K010042.

Who is the listed applicant for CT PERFUSION 2?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT PERFUSION 2?

The FDA product code for CT PERFUSION 2 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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