MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E

Control, Pump Speed, Cardiopulmonary Bypass

MEDTRONIC BIO-MEDICUS, INC.

The following data is part of a premarket notification filed by Medtronic Bio-medicus, Inc. with the FDA for Medtronic Bio-medicus Bio-console Model 540e.

Pre-market Notification Details

Device IDK924206
510k NumberK924206
Device Name:MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E
ClassificationControl, Pump Speed, Cardiopulmonary Bypass
Applicant MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie,  MN  55344
ContactThomas K Johnsen
CorrespondentThomas K Johnsen
MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie,  MN  55344
Product CodeDWA  
CFR Regulation Number870.4380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-20
Decision Date1993-05-07

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