BT-795/P AUTOMATED AUTOTRANS

Apparatus, Autotransfusion

ELECTROMEDICS, INC.

The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Bt-795/p Automated Autotrans.

Pre-market Notification Details

Device IDK860306
510k NumberK860306
Device Name:BT-795/P AUTOMATED AUTOTRANS
ClassificationApparatus, Autotransfusion
Applicant ELECTROMEDICS, INC. P.O. BOX 3315 Englewood,  CO  80155
ContactGary D Reeder
CorrespondentGary D Reeder
ELECTROMEDICS, INC. P.O. BOX 3315 Englewood,  CO  80155
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-28
Decision Date1986-03-06

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