YA HORNG ELECTRONIC CO., LTD.

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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

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (6) Thermometer, Electronic, Clinical (FLL) (2)

Premarket Exempt

No Yes

Clear

WITHINGS - 04719873310005 Catalog Number :

Device Description : BP-801 is the device for the measurement of blood pressure & pulse rate of patient

Device Class :

Duns Number: 656103819

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

WITHINGS - 04719873310012 Catalog Number :

Device Description : SCT01 is the device for the measurement of body temperature.

Device Class :

Duns Number: 656103819

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

WITHINGS - 04719873310029 Catalog Number :

Device Description : BP-801 is the device for the measurement of blood pressure & pulse rate of patient.

Device Class :

Duns Number: 656103819

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

WITHINGS - 04719873310036 Catalog Number :

Device Description : BP-801 is the device for the measurement of blood pressure & pulse rate of patient.

Device Class : 2

Duns Number: 656103819

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

NOKIA - 04719873310043 Catalog Number :

Device Description : BP-801 is the device for the measurement of blood pressure & pulse rate of patient.

Device Class : 2

Duns Number: 656103819

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

NOKIA - 04719873310050 Catalog Number :

Device Description : BP-801 is the device for the measurement of blood pressure & pulse rate of patient.

Device Class : 2

Duns Number: 656103819

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

NOKIA - 04719873310067 Catalog Number :

Device Description : SCT01 is the device for the measurement of body temperature.

Device Class :

Duns Number: 656103819

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

GARMIN - 04719873310074 Catalog Number :

Device Description : INDEX™ tubeless blood pressure monitor.

Device Class : 2

Duns Number: 656103819

Premarket Exempt : Yes

Product Code : DXN

Prescription Use : No

Device Count : 1

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