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Found 6 results
510(k) Data Aggregation
K Number
K151415Device Name
Oregon Scientific
Manufacturer
Date Cleared
2015-10-21
(147 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
IDT TECHNOLOGY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K131245Device Name
OREGON SCINTIFIC
Manufacturer
Date Cleared
2014-01-17
(261 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
IDT TECHNOLOGY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
By using oscillometric method, the device measure automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. This device is intended for use on adults for age 18 and above. The cuff size is fit for arm circumference of 22-32 cm. The device has the irregular heartbeat indicator feature. The color bar gives a warning signal with readings. The BPU321 can be compatible with the device of Bluetooth Smart-enabled. All values will be read out in LCD panel.
Device Description
Not Found
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K Number
K050083Device Name
BLOOD-PRESSURE METER, BPW120
Manufacturer
Date Cleared
2005-04-08
(85 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
IDT TECHNOLOGY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.
Device Description
Blood-pressure meter, Model BPW120
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K Number
K031167Device Name
HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
Manufacturer
Date Cleared
2004-01-28
(289 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
IDT TECHNOLOGY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.
The intended use of this device is for 7 to 99 years old normal subjects and not for I he intended use of ans econmended personal with implanted internal device like pacemaker or pregnant women to use this device.
Device Description
The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.
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K Number
K020433Device Name
FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER
Manufacturer
Date Cleared
2002-07-11
(153 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
IDT TECHNOLOGY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FT101 Forehead Thermometer is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.
Device Description
The FT101 Forehead Thermometer is an over-the-counter, non-sterile, reusable, nonpredictive clinical electronic thermometer designed to measure and assess the temperature of humans of all age ranges using an infrared detector to detect heat emission from the forehead. The measured temperature correlates to axillary temperature, and is displayed on a built-in LCD display. Calendar/clock functions are provided, and a memory function stores up to 10 temperature readings. The temperature reading range is 34 °C – 42.2 °C (92.3 F to 108.0 F), and the time of measurement is approximately 2 seconds, with a recommended cycle time of at least 30 seconds between readings. The unit operates in an ambient temperature range of 16 C – 35 C (61 F to 95 F). The FT101 Forehead Thermometer is entirely self-contained within one housing, and is battery-powered. The device is compact in size and weight, easy to use, portable and may be used in a variety of home or clinical settings.
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K Number
K021252Device Name
BLOOD-PRESSURE METER
Manufacturer
Date Cleared
2002-06-17
(59 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
IDT TECHNOLOGY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.
Device Description
Blood-pressure meter, Model BPW128
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