BIO-CAL 370 HEATER/COOLER

System, Thermal Regulating

BIO MEDICUS, INC.

The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio-cal 370 Heater/cooler.

Pre-market Notification Details

Device IDK894980
510k NumberK894980
Device Name:BIO-CAL 370 HEATER/COOLER
ClassificationSystem, Thermal Regulating
Applicant BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie,  MN  55344
ContactThomas K Johnsen
CorrespondentThomas K Johnsen
BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie,  MN  55344
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-08
Decision Date1989-11-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00673978537474 K894980 000
00673978537467 K894980 000

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