RIGHT VENTRICULAR EJECTION FRACTION-— 510(k) K842105

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K842105 for RIGHT VENTRICULAR EJECTION FRACTION-, Substantially Equivalent on 1985-01-15. Applicant: American Edwards Laboratories.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DXG
Advisory panel: Cardiovascular
Date received: 1984-05-25
Decision date: 1985-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.