MEDONE LLC

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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) (2) Monitor, Ultrasonic, Fetal (KNG) (1) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

Clear

MedOne - 00864243000407 Catalog Number :

Device Description : Blood Pressure Monitor

Device Class : 2

Duns Number: 080800987

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

MedOne - 00864243000414 Catalog Number :

Device Description : Fetal Heartbeat Monitor

Device Class : 2

Duns Number: 080800987

Premarket Exempt : No

Product Code : KNG

Prescription Use : No

Device Count : 1

MedOne - 00864243000421 Catalog Number :

Device Description : Forehead Thermometer

Device Class : 2

Duns Number: 080800987

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

MedOne - 00864243000445 Catalog Number :

Device Description : Blood Pressure Monitor

Device Class : 2

Duns Number: 080800987

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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