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FDA 510(k)

GE DIASONICS GATEWAY AND GATEWAY FX

K-Number: K993069 · 1999-09-22

ApplicantGeneral Electric Co.
Decision Date1999-09-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE DIASONICS GATEWAY AND GATEWAY FX 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 1999-09-22 under 510(k) number K993069. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE DIASONICS GATEWAY AND GATEWAY FX?

GE DIASONICS GATEWAY AND GATEWAY FX is a medical device that received FDA 510(k) clearance on 1999-09-22. The listed applicant is General Electric Co.. The 510(k) number is K993069.

When did GE DIASONICS GATEWAY AND GATEWAY FX receive FDA 510(k) clearance?

GE DIASONICS GATEWAY AND GATEWAY FX received FDA 510(k) clearance on 1999-09-22, under 510(k) number K993069.

Who is the listed applicant for GE DIASONICS GATEWAY AND GATEWAY FX?

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 GE DIASONICS GATEWAY AND GATEWAY FX?

The FDA product code for GE DIASONICS GATEWAY AND GATEWAY FX is IYO.

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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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