Cleared Traditional

PulsioFlex Monitoring System

K172259 · Pulsion Medical Systems SE · Cardiovascular
Jan 2018
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K172259 is an FDA 510(k) clearance for the PulsioFlex Monitoring System, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Pulsion Medical Systems SE (Feldkirchen, DE). The FDA issued a Cleared decision on January 18, 2018, 175 days after receiving the submission on July 27, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number K172259 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2017
Decision Date January 18, 2018
Days to Decision 175 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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