STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05

Detector, Bubble, 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 Air Purge Control System Model 23-45-05.

Pre-market Notification Details

Device IDK103469
510k NumberK103469
Device Name:STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
ClassificationDetector, Bubble, 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 CodeKRL  
CFR Regulation Number870.4205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-24
Decision Date2011-01-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04033817901693 K103469 000

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