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FDA 510(k)

DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE

K-Number: K863132 · 1987-01-14

ApplicantGeneral Electric Co.
Decision Date1987-01-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE 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 1987-01-14 under 510(k) number K863132. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE?

DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE is a medical device that received FDA 510(k) clearance on 1987-01-14. The listed applicant is General Electric Co.. The 510(k) number is K863132.

When did DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE receive FDA 510(k) clearance?

DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE received FDA 510(k) clearance on 1987-01-14, under 510(k) number K863132.

Who is the listed applicant for DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE?

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 DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE?

The FDA product code for DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE is LLZ.

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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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