STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER

Console, Heart-lung Machine, Cardiopulmonary Bypass

SORIN GROUP DEUTSCHLAND GMBH

The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Stockert S5 System, Stockert Gas Blender.

Pre-market Notification Details

Device IDK080832
510k NumberK080832
Device Name:STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
ClassificationConsole, Heart-lung Machine, Cardiopulmonary Bypass
Applicant SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro,  MA  02760
ContactRosina Robinson
CorrespondentRosina Robinson
SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro,  MA  02760
Product CodeDTQ  
CFR Regulation Number870.4220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-25
Decision Date2008-07-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04033817900719 K080832 000
04033817900702 K080832 000
04033817900696 K080832 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.