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510(k) Data Aggregation
K Number
K134043Device Name
NO TOUCH+FOREHEAD NTF 3000 THERMOMETER
Manufacturer
KAZ USA, INC (A SUBSIDIARY OF KAZ INC)
Date Cleared
2014-05-21
(141 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
KAZ USA, INC (A SUBSIDIARY OF KAZ INC)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The No Touch + Forehead Thermometer (Model NTF3000US) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch on the centre of the forehead as the measurement site on people of all ages.
Device Description
The No Touch+Forehead Thermometer ( Model NTF3000US) is a hand-held, battery powered device designed to measure human body temperature. The NTF3000 is an Infrared thermometer that converts a user's forehead temperature using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when placed in contact with the subject's forehead or up to two (2) inches away. The NTF 3000 thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection of contact or non-contact use and compensation of the temperature reading.
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K Number
K103800Device Name
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS
Manufacturer
KAZ USA, INC (A SUBSIDIARY OF KAZ INC)
Date Cleared
2011-01-26
(29 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
KAZ USA, INC (A SUBSIDIARY OF KAZ INC)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Braun Thermoscan® IRT 4000 series and Braun Thermoscan® PRO 4000 series Clinical Infrared Ear Thermometers is indicated for the intermittent measurement and monitoring of human body temperature by consumers of all ages in a home use/professional use environment respectively. The probe cover is used as a sanitary barrier between the infra-red thermometer and the ear canal.
Device Description
The Braun Thermoscan® Pro/IRT 4000 series thermometer is a hand held instrument (thermometer) that measures the natural thermal infrared radiation emitted from the tympanic membrane and adjacent surfaces with a built-in compensation algorithm to compensate the influence of ambient temperature using a heated tip. The Pro 4000 series thermometer is meant for professional use in hospitals and professional office settings, while the IRT 4000 series is meant for home use. The thermometer includes a probe cover that is used as a sanitary barrier between the thermometer and the ear canal to prevent any ear secretions or particulates from being transferred between different users.
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