ELECTROMEDICS D1079E

Heat-exchanger, Cardiopulmonary Bypass

ELECTROMEDICS, INC.

The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Electromedics D1079e.

Pre-market Notification Details

Device IDK873561
510k NumberK873561
Device Name:ELECTROMEDICS D1079E
ClassificationHeat-exchanger, Cardiopulmonary Bypass
Applicant ELECTROMEDICS, INC. P.O. BOX 3315 Englewood,  CO  80155
ContactDennis Mcelwee
CorrespondentDennis Mcelwee
ELECTROMEDICS, INC. P.O. BOX 3315 Englewood,  CO  80155
Product CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-02
Decision Date1987-11-05

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