SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER— 510(k) K841401

Name: FDA 510(k) clearance K841401
Creator: U.S. Food and Drug Administration
Published: 1985-01-14

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K841401 for SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER, Substantially Equivalent on 1985-01-14. 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: 1984-04-03
Decision date: 1985-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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