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510(k) Data Aggregation
K Number
K032612Device Name
IR FOREHEAD THERMOMETER, MODEL HV-T36
Manufacturer
Date Cleared
2004-02-19
(178 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ORIENTAL INSPIRATION LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.
Device Description
This device is an electronic infrared digital forehead thermometer. It scans the forehead area for temperature of the arterial blood supply under the skin. The thermometer displays the results digitally as well as by talking, between 35℃ (95ºF) and 42.2ºC (108ºF). This device includes also display of current date and time. Range of date display falls within Gregorian calendar year 1901~2099, time display includes 12 hours shift or 24 hours shift. HV-T36 stores up to 30 sets of measurement records. Each set has a maximum storage time of 30 days. Temperature is stored together with measuring date and time of measurement.
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