CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410— 510(k) K043454

Name: FDA 510(k) clearance K043454
Creator: U.S. Food and Drug Administration
Published: 2005-03-24

Substantially Equivalent

Medicomp, Inc.

FDA 510(k) clearance K043454 for CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410, Substantially Equivalent on 2005-03-24. Applicant: Medicomp, Inc.. Device class: 2.

Clearance details

Applicant: Medicomp, Inc.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2004-12-15
Decision date: 2005-03-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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