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510(k) Data Aggregation
K Number
K172121Device Name
Digital Thermometer
Manufacturer
Fudakang Industrial Co., Ltd
Date Cleared
2018-06-07
(329 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Fudakang Industrial Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Digital thermometers (Model: TP-100, TP-300, TP-300, TP-500, BT-A31A-BT) is intended for the measurement and monitoring of oral or axillary for adult , pediatric and infant temperature via thermistor by doctor or consumers in the hospital or home. The result of measurement and monitoring will be transmitted via Bluetooth enabled smart mobile device (cell phone, iPad) with GuardiAngel App installed.
Device Description
The Digital Thermometer is a general purpose thermometer is intended for oral or axillary temperature measurements of the human body. The thermometer should be used with a smart phone or other Bluetooth smart device on which the GuadiAngel app is installed. The thermometer communicates with the user's device through a Bluetooth connection.
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K Number
K160308Device Name
Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
Manufacturer
Fudakang Industrial Co., Ltd
Date Cleared
2016-07-15
(162 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Fudakang Industrial Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fudakang Bluetooth Digital thermometer (Model: BT-A41CN-BT) is intended for the measurement and monitoring of oral, axillary, and rectal temperature of adults via a thermistor. The device is for use of a doctor or lay consumers in the hospital or home. The result of measurement can be transmitted to smart mobile device (cell phone, iPad) while displayed on the LCD.
Device Description
Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
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K Number
K150430Device Name
Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor
Manufacturer
FUDAKANG INDUSTRIAL CO., LTD
Date Cleared
2015-04-17
(57 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
FUDAKANG INDUSTRIAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are non-invasive blood measurement system intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments.
The Fudakang BT series Blood Pressure Monitors are of Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile phone or PC through Bluetooth.
Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are not intended to be diagnostic device.
Device Description
Fudakang Blood Pressure Monitor is battery driven automatic non-invasive Blood Pressure Monitor.
It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique.
Fudakang Blood Pressure Monitor includes two types of automatic non-invasive Blood Pressure Monitor, Arm Automatic Blood Pressure Monitor and Wrist Fully Automatic Blood Pressure Monitor. The Arm Blood Pressure Monitor utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to 22cm-30cm (8.66 in - 11.8 in). The Wrist Blood Pressure Monitor utilizes an inflatable cuff wrapped around the wrist, the cuff circumference is limited to 13.5cm- 19.5cm (5.31in -7.67 in).
The BT series Blood Pressure Monitors are of Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile phone or PC through Bluetooth.
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