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510(k) Data Aggregation
K Number
K132761Device Name
WIRELESS THERMOMETER
Manufacturer
RAIING MEDICAL COMPANY
Date Cleared
2014-07-08
(307 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
RAIING MEDICAL COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wireless Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons over two years old.
Device Description
The wireless thermometer, WT701, which is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously. For the monitoring operation, switch the thermometer on and stick the thermometer in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measures the body temperature by means of testing the NTC resistance value and calculates the body temperature every 4 seconds continuously and sends the temperature data to the receiver through Bluetooth connection. The wireless thermometer uses a CR2032 battery for operation. When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.
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