1BYONEPRODUCTS INC.

Address:1230 E Belmont Street,Ontario,CA,91761,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

Oximeter (DQA) (1) Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

Clear

1BYONE - 00863696000309 Catalog Number :

Device Description : Arm blood pressure monitor

Device Class :

Duns Number: 845019202

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

1BYONE - 00863696000323 Catalog Number :

Device Description : Pulse Oximeter

Device Class : 2

Duns Number: 845019202

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

1BYONE - 00863696000347 Catalog Number :

Device Description : Infrared Thermometer

Device Class : 2

Duns Number: 845019202

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

1BYONE - 00863696000361 Catalog Number :

Device Description : Electronic Pulse Stimulator set

Device Class : 2

Duns Number: 845019202

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

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