SORIN CONNECT DATA MANAGEMENT SYSTEM

Display, Cathode-ray Tube, Medical

SORIN GROUP DEUTSCHLAND GMBH

The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Sorin Connect Data Management System.

Pre-market Notification Details

Device IDK131816
510k NumberK131816
Device Name:SORIN CONNECT DATA MANAGEMENT SYSTEM
ClassificationDisplay, Cathode-ray Tube, Medical
Applicant SORIN GROUP DEUTSCHLAND GMBH LINDBERGH STRASSE 25 Munchen,  DE 80939
ContactRenate Goebert
CorrespondentOlaf Teichert
TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton,  MN  55112 -1891
Product CodeDXJ  
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2013-06-20
Decision Date2013-07-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04033817901587 K131816 000
04033817901570 K131816 000
04033817900689 K131816 000
04033817900672 K131816 000

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