Cleared Traditional

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

K132528 · GE Healthcare Finland Oy · Cardiovascular

Jan 2014

Decision

157d

Days

Class 2

Risk

K132528 is an FDA 510(k) clearance for the E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES. This device is classified as a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG).

Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on January 16, 2014, 157 days after receiving the submission on August 12, 2013.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number	K132528 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2013
Decision Date	January 16, 2014
Days to Decision	157 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF