Blackbox Remote Patient Monitoring LLC

Address:13317 S. Moorfield Dr,Herriman,UT,84096,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

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (3) Oximeter (DQA) (1) Scale, Patient (FRW) (1)

Premarket Exempt

No Yes

Clear

BlackBox - B963101C1 Catalog Number :

Device Description : Cellular Blood Pressure Monitor

Device Class :

Duns Number: 117652799

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

BlackBox RPM - B963102C1 Catalog Number :

Device Description : Cellular Blood Pressure monitor

Device Class :

Duns Number: 117652799

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

BlackBox RPM - B963BPM201W1 Catalog Number :

Device Description : Blood Pressure monitor designed to be used seamlessly with our proprietary hub o Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.

Device Class :

Duns Number: 117652799

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

BlackBox RPM - B963PO401W1 Catalog Number :

Device Description : Pulse Oximeter

Device Class : 2

Duns Number: 117652799

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

BlackBox - B963WS501C0 Catalog Number :

Device Description : Cellular weight scale with a large platform and high weight capacity

Device Class : 1

Duns Number: 117652799

Premarket Exempt : Yes

Product Code : FRW

Prescription Use : No

Device Count : 1

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