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510(k) Data Aggregation
K Number
K964851Device Name
ENTRACARE THERMOMTER MODEL 1000
Manufacturer
Date Cleared
1997-02-03
(62 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ENTRACARE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EntraCare Thermometer, Model 1000, is intended to be used under a physicians orders when an accurate temperature measurement is required. The device is intended to be used orally or rectally in the human body temperature range of 92°F to 108°F. It may be used with infants, children, or adults in all settings under the order of a physcian. The heart rate timer is also provided to aid in establishing a patients approximate heart rate.
Device Description
The EntraCare Thermometer, Model 1000, is a hand-held, battery powered thermometer. This thermometer is capable of measuring and displaying temperatures over the entire human body temperature range (92.0° to 108.0° F or 33.0° to 42.0° C). This device also is capable of calculating a persons approximate heart rate through the use of a stopwatch type function and will display the rate simultaneously with temperature. This feature acts like a stop watch and does not attempt to directly measure a patients pulse.
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