HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

Thermometer, Electronic, Clinical

MALLINCKRODT CRITICAL CARE

The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Hi-lo Temp(r) Skin Temperature Sensor.

Pre-market Notification Details

Device IDK874404
510k NumberK874404
Device Name:HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
ClassificationThermometer, Electronic, Clinical
Applicant MALLINCKRODT CRITICAL CARE HOOK RD. Argyle,  NY  12809
ContactPhilip E Wiegert
CorrespondentPhilip E Wiegert
MALLINCKRODT CRITICAL CARE HOOK RD. Argyle,  NY  12809
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-28
Decision Date1987-11-06

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