Cleared Traditional

PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM

K001762 · Pulsion Medical Systems, Inc. · Cardiovascular

Jun 2000

Decision

Days

Class 2

Risk

About This 510(k) Submission

K001762 is an FDA 510(k) clearance for the PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Pulsion Medical Systems, Inc. (Cornelius, US). The FDA issued a Cleared decision on June 13, 2000, 4 days after receiving the submission on June 9, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number	K001762 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2000
Decision Date	June 13, 2000
Days to Decision	4 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF