RIGHT VENTRICULAR EJECTION FRACTION-— 510(k) K842105

Name: FDA 510(k) clearance K842105
Creator: U.S. Food and Drug Administration
Published: 1985-01-15

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. Device class: 2.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
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 ↗

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