E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES— 510(k) K132528

Name: FDA 510(k) clearance K132528
Creator: U.S. Food and Drug Administration
Published: 2014-01-16

Substantially Equivalent

GE Healthcare Finland Oy

FDA 510(k) clearance K132528 for E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES, Substantially Equivalent on 2014-01-16. Applicant: GE Healthcare Finland Oy. Device class: 2.

Clearance details

Applicant: GE Healthcare Finland Oy
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2013-08-12
Decision date: 2014-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.