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510(k) Data Aggregation
K Number
K041646Device Name
THERMOTEK Q5
Manufacturer
Date Cleared
2004-07-22
(35 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
SAAT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ThermoTek Q5 is intended for taking body temperature orally, rectally or under the arm.
Device Description
The device is an electronic contact thermometer. It consists of a commercial thermistor in a stainless steel cap, a tip and rigid plastic housing that contains a PCBA, a LCD and two flexible buttons (On and Mode). The device is operated on a single 3V Lithium battery. Thanks to its small size, the thermistor reaches a thermal equilibrium with the measured subject in about 5 seconds in a bath and in oral and rectal modes, and in about 20 sec in axial mode.
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K Number
K010502Device Name
MODEL THERMO TEK QUICKCARE
Manufacturer
Date Cleared
2001-02-27
(6 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
SAAT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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