AVITA CORPORATION

Address:9F, NO. 78, SEC. 1,,San-Chung District, New Taipei City,TW

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Thermometer, Electronic, Clinical (FLL) (5) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (4)

Premarket Exempt

Clear

Blood pressure monitor - 04710953420942 Catalog Number :

Device Description : The device is a wrist type blood pressure monitor intended for automatically mea The device is a wrist type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the wrist. The device is intended to be used by adults with a wrist circumference ranging from 125mm to 210mm (approx. 4.9 to 8.3 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.

Device Class : 2

Duns Number: 658023275

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Blood pressure monitor - 04710953421161 Catalog Number :

Device Description : The device is a arm type blood pressure monitor intended for automatically measu The device is a arm type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the arm.The cuff circumference is limited to 220 mm - 420 mm (approx.:9 - 17 inches).The device is intended for home use. When the device detects irregular heart beats during measurement, an irregular heartbeat symbol will appear along with the measured readings

Device Class :

Duns Number: 658023275

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

TekCare Touch Free Infrared Thermometer - 04710953421291 Catalog Number :

Device Description : The NT11 THERMO DISTANCE thermometer is designed for the intermittent measuremen The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in a domestic environment, and can be used upon people of all ages.

Device Class : 2

Duns Number: 658023275

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TekCare Infrared Thermometer - 04710953421314 Catalog Number :

Device Description : The device is an infrared thermometer intended for the intermittent measurement The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

Device Class : 2

Duns Number: 658023275

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TekCare Blood Pressure Monitor - 04710953421338 Catalog Number :

Device Description : BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and heart rate. All values are shown on the LCD monitor. This device is designed only for adults.

Device Class : 2

Duns Number: 658023275

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

TekCare Green-Type Infrared Thermometer - 04710953421468 Catalog Number :

Device Description : The IR Thermometer is intended to be used as the intermittent measurement of hum The IR Thermometer is intended to be used as the intermittent measurement of human body temperature for people of all ages.

Device Class :

Duns Number: 658023275

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TekCare Touch Free Infrared Thermometer - 04710953421512 Catalog Number :

Device Description : The NT17 THERMO DISTANCE thermometer is designed for the intermittent measuremen The NT17 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment and can be used upon people of all ages

Device Class : 2

Duns Number: 658023275

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TekCare Non-Contact Infrared Thermometer - 04710953421598 Catalog Number :

Device Description : The NT19 thermometer is designed for the intermittent measurement of the human b The NT19 thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment and can be used upon people of all ages

Device Class : 2

Duns Number: 658023275

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Harbor Freight Tools - 04710953421628 Catalog Number :

Device Description : The product automatically measures human begins Systolic, Diastolic blood pressu The product automatically measures human begins Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults with wrist circumference ranging from 125 mm to 210 mm (Approx.4.9 ~ 8.3 inches) and for home use. When the device detects the appearance of irregular heartbeats such as atrial or ventricular premature beats during measurement, an indicated symbol will appear with measuring readings. This device is designed only for adults.

Device Class : 2

Duns Number: 658023275

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Previous 1 Next