Cleared Special

PULSION PICCO-2, MODEL 8500

K072735 · Pulsion Medical Systems AG · Cardiovascular
Oct 2007
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K072735 is an FDA 510(k) clearance for the PULSION PICCO-2, MODEL 8500, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Pulsion Medical Systems AG (Wake Forest, US). The FDA issued a Cleared decision on October 18, 2007, 21 days after receiving the submission on September 27, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number K072735 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2007
Decision Date October 18, 2007
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DXG — Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1435

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