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510(k) Data Aggregation
K Number
K214077Device Name
Digital Thermometer, Model: DT007, DT008
Manufacturer
Guangzhou Berrcom Medical Device Co., Ltd.
Date Cleared
2023-01-20
(389 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Berrcom Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
DT008 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
Device Description
The basic principle of Digital Thermometer is that a change in thermistor resistance is caused by a change in temperature. The device measure body temperature by using a direct mode. The resistance is measured by a microcontroller unit, so that changes in temperature will correspond to changes in resistance. And the temperature value is displayed on the LCD screen. The device can be used for axillary, oral in the home, and used for axillary, oral and rectal temperature measurement in the hospital. The device is reusable and provided non-sterile. The device is intended for use on people of all ages. The probe cover is required when measuring the oral or rectal temperature, but not when measuring the axillary temperature.
The Digital Thermometer includes two models: DT007 and DT008. The differences of these two models are in appearance, PCB layout, external dimension and weight. All of them have the same function and they have the following basic functions:
- Data displayed on LCD
- Automatic stop (energy saver)
- Small, convenient, easy to use
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K Number
K213746Device Name
Digital thermometer, Model DT101, DT102
Manufacturer
Guangzhou Berrcom Medical Device Co., Ltd.
Date Cleared
2022-04-05
(127 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Berrcom Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K213084Device Name
Ear Thermometer, Model ET005, ET008, ET009
Manufacturer
Guangzhou Berrcom Medical Device Co., Ltd.
Date Cleared
2022-02-25
(155 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Berrcom Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ear Thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It is a non-contact method for forehead measurement, the recommended measurement distance is 0cm. The Ear Thermometer can be used by consumers in the household environment and by healthcare providers.
Device Description
The Ear Thermometers are a hand-held, battery powered infrared thermometer. It is intended to measure the temperature of human body from ear or forehead. The infrared sensor contained in the device can monitor the energy radiated from the human ear tympanum and forehead. The device can analyze and processes the signal transmitted by the infrared sensor, and finally displays it on the screen in digital form to achieve the measurement of human body temperature. People of all ages in household environment and doctors in clinic as reference are suitable for using the device.
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K Number
K213079Device Name
Ear Thermometer, Model ET001
Manufacturer
Guangzhou Berrcom Medical Device Co., Ltd.
Date Cleared
2022-02-18
(148 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Berrcom Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ear Thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It is a non-contact method for forehead measurement, the recommended measurement distance is 0cm. The Ear Thermometer can be used by consumers in the household environment and by healthcare providers.
Device Description
The Ear Thermometer, model of ET001 is a hand-held, battery powered infrared thermometer. It is intended to measure the temperature of human body from ear or forehead. The infrared sensor contained in the device can monitor the energy radiated from the human ear tympanum and forehead. The device can analyze and processes the signal transmitted by the infrared sensor, and finally displays it on the screen in digital form to achieve the measurement of human body temperature. People of all ages in household environment and doctors in clinic as reference are suitable for using the device.
It has the following features:
1) Forehead and ear temperature measurement.
2) Fahrenheit and Celsius temperature unit setting.
3) Display resolution is 0.1°C (0.1°F);
4) Memorize the latest 10 measurement data;
5) Three color backlight display (red, orange, green)
6) Low battery indication.
7) Prompt for Measurement completion.
8) Buzzer feature setting (mute or unmute)
9) Turn off automatically after 75 seconds of inactivity.
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K Number
K213082Device Name
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
Manufacturer
Guangzhou Berrcom Medical Device Co., Ltd.
Date Cleared
2022-01-28
(127 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Berrcom Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Non-Contact Infrared Thermometer, Models JXB-315, JXB-320, JXB-311, is a non-sterile, reusable, handheld device. It can be used by consumers in household environment and doctor in clinic as reference. It is intended for non-contact measuring of human body temperature of people of all ages (neonate, infant, pediatric, adult) by detecting infrared heat from the center of the forehead.
Device Description
The Non-contact Infrared Thermometer (include models JXB-315, JXB-320, JXB-311) is a hand-held forehead thermometer, and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature of human body which measures the body temperature based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages. The thermometer is also intended to measure the object temperature. After measurement, the temperature is directly displayed on the LED screen. These thermometers have the following features: 1) Body temperature mode 2) Fahrenheit and Celsius temperature unit setting LED display screen with automatic range selection, resolution is 0.1 degree Celsius (0.1 degree Fahrenheit) 3) 4) Memorize the latest 32 measurement data LED display screen 5) 6) Low battery indication 7) Measurement distance indication 8) Over range prompt (HI/LO) 9) Auto shutdown when the device is idle for 30 seconds 10) High temperature indication
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K Number
K191570Device Name
Infrared Thermometer Model MD-H30
Manufacturer
Guangzhou Berrcom Medical Device Co., Ltd.
Date Cleared
2019-11-13
(153 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Berrcom Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
Device Description
The Infrared Thermometer, Model MD-H30 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display.
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