Cleared Special

PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE

K122121 · Pulsion Medical Systems SE · Cardiovascular
Aug 2012
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K122121 is an FDA 510(k) clearance for the PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Pulsion Medical Systems SE (Westbrook, US). The FDA issued a Cleared decision on August 2, 2012, 16 days after receiving the submission on July 17, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number K122121 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2012
Decision Date August 02, 2012
Days to Decision 16 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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