Sorin Connect

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.

Pre-market Notification Details

Device IDK170460
510k NumberK170460
Device Name:Sorin Connect
ClassificationDisplay, Cathode-ray Tube, Medical
Applicant Sorin Group Deutschland GmbH Lindberghstrasse, 25 Munich,  DE 80939
ContactLuigi Vecchi
CorrespondentScott Light
Sorin Group USA, Inc. 14401 W 65th Way Arvada,  CO  80004
Product CodeDXJ  
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-15
Decision Date2017-06-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04033817901594 K170460 000

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