ZEWA, INC.

Address:12960 Commerce Lakes Drive,Fort Myers,FL,33913,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) (10)

Premarket Exempt

No Yes

Clear

Zewa - 00682891338006 Catalog Number :

Device Description : Wrist BP Monitor

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Sokkar - 00682891341006 Catalog Number :

Device Description : BP Monitor UAM-410CA

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Zewa - 00682891371003 Catalog Number :

Device Description : BP Monitor UAM-710

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Zewa - 00682891372000 Catalog Number :

Device Description : BP Monitor

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Zewa - 00682891382009 Catalog Number :

Device Description : BP Monitor UAM-820BT

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Zewa - 00682891383006 Catalog Number :

Device Description : BP Monitor

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Zewa - 00682891383013 Catalog Number :

Device Description : BP Monitor

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Zewa - 00682891388001 Catalog Number :

Device Description : BP Monitor

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Zewa - 00682891388018 Catalog Number :

Device Description : BP Monitor

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Zewa - 00682891388070 Catalog Number :

Device Description : BP Monitor

Device Class : 2

Duns Number: 013481078

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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