Cleared Special

PULSIOFLEX

K112448 · Pulsion Medical Systems, Inc. · Cardiovascular
Sep 2011
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K112448 is an FDA 510(k) clearance for the PULSIOFLEX, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Pulsion Medical Systems, Inc. (Westbrook, US). The FDA issued a Cleared decision on September 22, 2011, 28 days after receiving the submission on August 25, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number K112448 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2011
Decision Date September 22, 2011
Days to Decision 28 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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