BIO MEDICUS BIO PUMP MODEL BP-80

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

BIO MEDICUS, INC.

The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio Medicus Bio Pump Model Bp-80.

Pre-market Notification Details

Device IDK852698
510k NumberK852698
Device Name:BIO MEDICUS BIO PUMP MODEL BP-80
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie,  MN  55344
ContactJohn R Dalpee
CorrespondentJohn R Dalpee
BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie,  MN  55344
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-26
Decision Date1985-09-30

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