CARDIOMAX-II— 510(k) K861543

Substantially Equivalent

Columbus Instruments Intl. Corp.

FDA 510(k) clearance K861543 for CARDIOMAX-II, Substantially Equivalent on 1987-03-10. 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: 1986-04-24
Decision date: 1987-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, US

Download summary PDF View on FDA.gov ↗

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