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510(k) Data Aggregation
K Number
K983619Device Name
BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER
Manufacturer
Date Cleared
1998-11-02
(18 days)
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
BARCHENS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Barchens Digital Pacifier Thermometer is a non-sterile, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five years of age.
Device Description
The Barchens Digital Pacifier Thermometer, is a battery-powered, liquid crystal display device using a thermometer embedded in the nipple. The patient contact portion is composed of medical silicone rubber. The body is of ABS plastic . This device is reusable and no components are disposable. This device is not intended for use with other sheaths or devices.
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