SORENSON THERMODILUTION CARDIAC COMPUT— 510(k) K812757

Name: FDA 510(k) clearance K812757
Creator: U.S. Food and Drug Administration
Published: 1981-11-02

Substantially Equivalent

Sorensen Research

FDA 510(k) clearance K812757 for SORENSON THERMODILUTION CARDIAC COMPUT, Substantially Equivalent on 1981-11-02. Applicant: Sorensen Research. Device class: 2.

Clearance details

Applicant: Sorensen Research
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1981-09-30
Decision date: 1981-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.