Cleared Traditional

SORIN CONNECT DATA MANAGEMENT SYSTEM

K131816 · Sorin Group Deutschland GmbH · Cardiovascular
Jul 2013
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K131816 is an FDA 510(k) clearance for the SORIN CONNECT DATA MANAGEMENT SYSTEM, a Display, Cathode-ray Tube, Medical (Class II — Special Controls, product code DXJ), submitted by Sorin Group Deutschland GmbH (Munich, DE). The FDA issued a Cleared decision on July 23, 2013, 33 days after receiving the submission on June 20, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number K131816 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2013
Decision Date July 23, 2013
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXJ — Display, Cathode-ray Tube, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2450

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