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510(k) Data Aggregation
K Number
K111463Device Name
VALEO VT-601 SERIES IR THERMOMETER
Manufacturer
VALEO CORP.
Date Cleared
2012-02-17
(267 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
VALEO CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E, VT-601F) is infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
Device Description
The Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E . VT-601F) is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature. The Valeo VT-601D IR Forehead/ Ear Thermometer can measure human body temperature in 2 ways: (1) The temporal artery over forehead. (2) Tympanic temperature via the human ear. The Valeo VT-601E IR Ear Thermometer measures human body temperature natural thermal infrared radiation emitted from the ear tympanic. The Valeo VT-601F IR Forehead Thermometer measure human body temperature by the temporal artery over forehead. Operation is based on the measuring of the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery or from the ear tympanic.
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K Number
K002562Device Name
PACIFIER THERMOMETER MODELS VT-901F, VT901C
Manufacturer
VALEO CORP.
Date Cleared
2000-10-13
(57 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
VALEO CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K982140Device Name
CLINICAL ELECTRONIC THERMOMETER
Manufacturer
VALEO CORP.
Date Cleared
1998-12-08
(174 days)
Product Code
FLL, ELL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
VALEO CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Device Description
Clinical Electronic Thermometer
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