HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE

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) General Purpose Temperature Probe.

Pre-market Notification Details

Device IDK874514
510k NumberK874514
Device Name:HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
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 Received1987-11-02
Decision Date1988-01-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30884521031603 K874514 000
30884521031597 K874514 000
30884521828395 K874514 000
20884521828381 K874514 000

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