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FDA 510(k)

RIGHT VENTRICULAR EJECTION FRACTION-

K-Number: K842105 · 1985-01-15

ApplicantAmerican Edwards Laboratories
Decision Date1985-01-15
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RIGHT VENTRICULAR EJECTION FRACTION- is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1985-01-15 under 510(k) number K842105. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIGHT VENTRICULAR EJECTION FRACTION-?

RIGHT VENTRICULAR EJECTION FRACTION- is a medical device that received FDA 510(k) clearance on 1985-01-15. The listed applicant is American Edwards Laboratories. The 510(k) number is K842105.

When did RIGHT VENTRICULAR EJECTION FRACTION- receive FDA 510(k) clearance?

RIGHT VENTRICULAR EJECTION FRACTION- received FDA 510(k) clearance on 1985-01-15, under 510(k) number K842105.

Who is the listed applicant for RIGHT VENTRICULAR EJECTION FRACTION-?

The FDA 510(k) record lists American Edwards Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIGHT VENTRICULAR EJECTION FRACTION-?

The FDA product code for RIGHT VENTRICULAR EJECTION FRACTION- is DXG.

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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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