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FDA 510(k)

860 COLOR DOPPLER OR COLORVIEW 860

K-Number: K861538 · 1986-08-25

ApplicantGe Medical Systems Information Technologies
Decision Date1986-08-25
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

860 COLOR DOPPLER OR COLORVIEW 860 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 1986-08-25 under 510(k) number K861538. 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 860 COLOR DOPPLER OR COLORVIEW 860?

860 COLOR DOPPLER OR COLORVIEW 860 is a medical device that received FDA 510(k) clearance on 1986-08-25. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K861538.

When did 860 COLOR DOPPLER OR COLORVIEW 860 receive FDA 510(k) clearance?

860 COLOR DOPPLER OR COLORVIEW 860 received FDA 510(k) clearance on 1986-08-25, under 510(k) number K861538.

Who is the listed applicant for 860 COLOR DOPPLER OR COLORVIEW 860?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 860 COLOR DOPPLER OR COLORVIEW 860?

The FDA product code for 860 COLOR DOPPLER OR COLORVIEW 860 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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