CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC— 510(k) K844116

Name: FDA 510(k) clearance K844116
Creator: U.S. Food and Drug Administration
Published: 1985-05-28

Substantially Equivalent

Critikon Company, LLC

FDA 510(k) clearance K844116 for CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC, Substantially Equivalent on 1985-05-28. Applicant: Critikon Company, LLC. Device class: 2.

Clearance details

Applicant: Critikon Company, LLC
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1984-10-23
Decision date: 1985-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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