OMNI THERM TEMPERATURE MONITOR

Strip, Temperature, Forehead, Liquid Crystal

OMNI THERM, INC.

The following data is part of a premarket notification filed by Omni Therm, Inc. with the FDA for Omni Therm Temperature Monitor.

Pre-market Notification Details

Device IDK864853
510k NumberK864853
Device Name:OMNI THERM TEMPERATURE MONITOR
ClassificationStrip, Temperature, Forehead, Liquid Crystal
Applicant OMNI THERM, INC. 7919 N. BROADWAY St. Louis,  MO  63147
ContactDale E Walters
CorrespondentDale E Walters
OMNI THERM, INC. 7919 N. BROADWAY St. Louis,  MO  63147
Product CodeKPD  
CFR Regulation Number880.2200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-11
Decision Date1987-02-04

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