CENTRIFUGAL PUMP

Control, Pump Speed, Cardiopulmonary Bypass

STOCKERT INSTRUMENTE GMBH

The following data is part of a premarket notification filed by Stockert Instrumente Gmbh with the FDA for Centrifugal Pump.

Pre-market Notification Details

Device IDK011838
510k NumberK011838
Device Name:CENTRIFUGAL PUMP
ClassificationControl, Pump Speed, Cardiopulmonary Bypass
Applicant STOCKERT INSTRUMENTE GMBH 49 PLAIN ST. North Attleboro,  MA  02760
ContactRosina Robinson
CorrespondentRosina Robinson
STOCKERT INSTRUMENTE GMBH 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeDWA  
CFR Regulation Number870.4380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-12
Decision Date2002-02-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04033817901532 K011838 000
04033817901525 K011838 000
04033817901518 K011838 000
04033817900986 K011838 000
04033817900979 K011838 000
04033817900931 K011838 000

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