IL 801 THERMALDILUTION CARDIAC OUTPUT— 510(k) K822972

Name: FDA 510(k) clearance K822972
Creator: U.S. Food and Drug Administration
Published: 1982-11-01

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K822972 for IL 801 THERMALDILUTION CARDIAC OUTPUT, Substantially Equivalent on 1982-11-01. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1982-10-08
Decision date: 1982-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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