CARDIAC CATHERIZATION LAB MICROPROCESS— 510(k) K820194

Name: FDA 510(k) clearance K820194
Creator: U.S. Food and Drug Administration
Published: 1982-05-25

Substantially Equivalent

Compu-Cath Corp.

FDA 510(k) clearance K820194 for CARDIAC CATHERIZATION LAB MICROPROCESS, Substantially Equivalent on 1982-05-25. Applicant: Compu-Cath Corp.. Device class: 2.

Clearance details

Applicant: Compu-Cath Corp.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1982-01-25
Decision date: 1982-05-25
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.