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510(k) Data Aggregation
K Number
K120004Device Name
(MULTIPLE) DIGITAL THERMOMETER
Manufacturer
Date Cleared
2012-08-23
(233 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
CHINA SHENYANG MED-LAND IMP/EXP CORP., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Digital Thermometer is used for the measurement and monitoring of human body temperature. Body temperature can be measured with the Digital Thermometer by oral, axillary (under the arm) and rectal methods. The device is for adult and pediatric use.
Device Description
The Digital Thermometer is a hand-held electronic thermometer comprised of an electronic thermoresistor (thermistor) sensor connected to a printed circuit board (PCB) with liquid crystal display (LCD) user readout. These components are held in a plastic housing with stainless steel metal cap. The housing is a rigid plastic. The Digital Thermometer is supplied with a clear plastic storage case to protect the thermometer.
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