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510(k) Data Aggregation
K Number
K103407Device Name
COTRONIC DIGITAL THERMOMETER
Manufacturer
Date Cleared
2011-05-13
(175 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
COTRONIC MANUFACTURING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This clinical electronic thermometer is used over the counter to measure the human body temperature orally, auxiliary, and through the rectum.
Device Description
The clinical electronic thermometer is used over the counter to measure the human body temperature orally, auxiliary, and through the rectum. The device has the following skin contact parts: stainless steel tip, ABS plastic housing, and Ethylene/Butylene-Styrene Block thermoplastic housing. The method used to measure the temperature of a human follows the standard ASTM E1112(Standard Specifications for Electronic Thermometer for Intermittent Determination of Patient Temperature).
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K Number
K032434Device Name
CLINICAL ELECTRONIC THERMOMETER
Manufacturer
Date Cleared
2004-12-27
(509 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
COTRONIC MANUFACTURING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device measures the human body temperature from oral, armpit, and rectal. The device is reuseable and intended for clinical or home use on people of all ages.
Device Description
The Clinical Electronic Thermometer is a thermometer intended for the determination of oral, axillary, and rectal body temperature determination in humans.
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