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510(k) Data Aggregation
K Number
K170723Device Name
Swaive Thermometer SWT1A
Manufacturer
Date Cleared
2018-10-25
(595 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
E-Care Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is an electronic clinical thermometer) to measure and monitor body temperature from auditory canal for people of all ages in a home set environment.
Device Description
The Swaive Thermometer SWT1A is a hand-held, battery-powered electronic thermometer which uses an infrared sensor to detect body temperature from the auditory canal. It is an infrared ear thermometer with disposable probe cover. It measures the thermal infrared radiation emitted from the tympanic membrane and the surrounding tissue by the sensor inside the probe. The electronic signal of sensor is amplified, calculated, converted into temperature value, and then displayed on LED board by the electronic circuit inside. It only takes a few seconds for the whole measurement process. Besides the temperature measurement circuit, a Bluetooth circuit is embedded in SWT1A to transmit the temperature value to smart phone via the specified App "Swaive Thermometer". This App only stores the temperature value on the smart phone if needed and has no clinical intention. SWT1A is a stand-alone device. It measures ear temperature and displays on its LED display with or without connecting with smart phone.
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