CARDIOTHERM-500X— 510(k) K771718

Name: FDA 510(k) clearance K771718
Creator: U.S. Food and Drug Administration
Published: 1977-09-28

Substantially Equivalent

Columbus Instruments Intl. Corp.

FDA 510(k) clearance K771718 for CARDIOTHERM-500X, Substantially Equivalent on 1977-09-28. Applicant: Columbus Instruments Intl. Corp.. Device class: 2.

Clearance details

Applicant: Columbus Instruments Intl. Corp.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1977-09-12
Decision date: 1977-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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