STOCKERT CENTRIFUGAL PUMP CONSOLE

Console, Heart-lung Machine, Cardiopulmonary Bypass

STOCKERT INSTRUMENTE GMBH

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

Pre-market Notification Details

Device IDK020571
510k NumberK020571
Device Name:STOCKERT CENTRIFUGAL PUMP CONSOLE
ClassificationConsole, Heart-lung Machine, Cardiopulmonary Bypass
Applicant STOCKERT INSTRUMENTE GMBH 49 PLAIN ST. North Attleboro,  MA  02760
ContactCynthia J.m. Nolte
CorrespondentCynthia J.m. Nolte
STOCKERT INSTRUMENTE GMBH 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeDTQ  
CFR Regulation Number870.4220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-21
Decision Date2002-09-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04033817901495 K020571 000
04033817901020 K020571 000
04033817901013 K020571 000
04033817900641 K020571 000
04033817900542 K020571 000

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