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510(k) Data Aggregation
K Number
K100660Device Name
INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000
Manufacturer
INNOCHIPS TECHNOLOGY CO., LTD.
Date Cleared
2010-10-22
(228 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
INNOCHIPS TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Infrared Ear Thermometer (Dr. Schven ICT-1000) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.
Device Description
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K Number
K081788Device Name
INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200
Manufacturer
INNOCHIPS TECHNOLOGY CO., LTD.
Date Cleared
2008-12-17
(176 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
INNOCHIPS TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Infrared Ear Thermometer (InnoTherm ICT-100 and InnoTherm ICT-200) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.
Device Description
Infrared Ear Thermometer offers easy, safe, accurate and fast temperature measurement in the ear. Temperature is more accurate core body temperature than other site of the body, since the eardrum shares blood vessels with the temperature control center in the brain (hypothalamus). Therefore, variations in body temperature are reflected sooner and more accurately in the ear than at the other sites on the body. Infrared Ear Thermometer is more convenient and safer than an oral thermometer, as it is unaffected by factors such as talking, eating, drinking and smoking.
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