Cleared Traditional

PulsioFlex Monitoring System with ProAQT Sensor

K192169 · Pulsion Medical Systems SE · Cardiovascular

Apr 2020

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K192169 is an FDA 510(k) clearance for the PulsioFlex Monitoring System with ProAQT Sensor, 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 April 30, 2020, 265 days after receiving the submission on August 9, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number	K192169 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2019
Decision Date	April 30, 2020
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF