STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE

Console, Heart-lung Machine, Cardiopulmonary Bypass

STOECKERT INSTRUMENTE

The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for Stockert S3 Roller Pump Module Stockert S3 Console.

Pre-market Notification Details

Device IDK950990
510k NumberK950990
Device Name:STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE
ClassificationConsole, Heart-lung Machine, Cardiopulmonary Bypass
Applicant STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro,  MA  02760
ContactDiane Minear
CorrespondentDiane Minear
STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeDTQ  
CFR Regulation Number870.4220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-03
Decision Date1996-01-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04033817901150 K950990 000

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