S3 CYCLIC RPM CONTROL

Pump, Blood, Cardiopulmonary Bypass, Roller Type

STOECKERT INSTRUMENTE

The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for S3 Cyclic Rpm Control.

Pre-market Notification Details

Device IDK971520
510k NumberK971520
Device Name:S3 CYCLIC RPM CONTROL
ClassificationPump, Blood, Cardiopulmonary Bypass, Roller Type
Applicant STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro,  MA  02760
ContactDiane Minear
CorrespondentDiane Minear
STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeDWB  
CFR Regulation Number870.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-25
Decision Date1997-09-10
Summary:summary

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