Cleared Traditional

PULSION PICCO PLUS, MODEL 8100

K060898 · Pulsion Medical Systems AG · Cardiovascular
Jul 2006
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K060898 is an FDA 510(k) clearance for the PULSION PICCO PLUS, MODEL 8100, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Pulsion Medical Systems AG (Raleigh, US). The FDA issued a Cleared decision on July 25, 2006, 113 days after receiving the submission on April 3, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number K060898 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2006
Decision Date July 25, 2006
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

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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