BL HEALTHCARE, INC.

Address:100 Foxboro Blvd, Suite 230,Foxboro,MA,02035,US

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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

Scale, Patient (FRW) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1) Thermometer, Electronic, Clinical (FLL) (1) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (1)

Premarket Exempt

No Yes

Clear

Healthcare Access Terminal - 00863353000307 Catalog Number :

Device Class : 2

Duns Number: 171081909

Premarket Exempt : No

Product Code : DRG

Prescription Use : Yes

Device Count : 1

BL Healthcare Blood Pressure Meter - 00863353000314 Catalog Number :

Device Class : 2

Duns Number: 171081909

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

BL Healthcare Bluetooth Weight Scale - 00863353000321 Catalog Number :

Device Class : 1

Duns Number: 171081909

Premarket Exempt : Yes

Product Code : FRW

Prescription Use : Yes

Device Count : 1

BL Healthcare Thermometer - 00863353000338 Catalog Number :

Device Class : 2

Duns Number: 171081909

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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