ALARM, THERMAL, THERM-ALERT

Strip, Temperature, Forehead, Liquid Crystal

RESPIRATORY CARE, INC.

The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Alarm, Thermal, Therm-alert.

Pre-market Notification Details

Device IDK760683
510k NumberK760683
Device Name:ALARM, THERMAL, THERM-ALERT
ClassificationStrip, Temperature, Forehead, Liquid Crystal
Applicant RESPIRATORY CARE, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKPD  
CFR Regulation Number880.2200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-09-20
Decision Date1976-09-27

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