FDA 510(k)

CT SYTEC 8000

K-Number: K913485 · 1992-01-23

Decision Date1992-01-23

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CT SYTEC 8000 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 1992-01-23 under 510(k) number K913485. 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 SYTEC 8000?

CT SYTEC 8000 is a medical device that received FDA 510(k) clearance on 1992-01-23. The listed applicant is General Electric Co.. The 510(k) number is K913485.

When did CT SYTEC 8000 receive FDA 510(k) clearance?

CT SYTEC 8000 received FDA 510(k) clearance on 1992-01-23, under 510(k) number K913485.

Who is the listed applicant for CT SYTEC 8000?

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 SYTEC 8000?

The FDA product code for CT SYTEC 8000 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.