NEWMAN MEDICAL LLC

Address:5350 VIVIAN STREET,Arvada,CO,80002,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

Doppler, Fetal, Ultrasound (LXE) (6) Monitor, Ultrasonic, Nonfetal (JAF) (4)

Premarket Exempt

Clear

DigiDop - 00852785008203 Catalog Number : DD-701-D3

Device Description : DigiDop 701, Display w recharger, 3MHZ OB

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008210 Catalog Number : DD-701-D3W

Device Description : DigiDop 701, Display w recharger, 3MHZ OB WATERPROOF

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008227 Catalog Number : DD-701-D5

Device Description : DigiDop 701, Display w recharger, 5MHZ VASCULAR

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008234 Catalog Number : DD-701-D8

Device Description : DigiDop 701, Display w recharger, 8MHZ VASCULAR

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008241 Catalog Number : DD-330-D2

Device Description : DD-II 330 Non-Display Doppler, 2MHz obstetrical probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008258 Catalog Number : DD-330-D2W

Device Description : DD-II 330 Non-Display Doppler, 2MHz waterproof obstetrical probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008265 Catalog Number : DD-330-D3

Device Description : DD-II 330 Non-Display Doppler, 3MHz obstetrical probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008272 Catalog Number : DD-330-D3W

Device Description : DD-II 330 Non-Display Doppler, 3MHz waterproof obstetrical probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008289 Catalog Number : DD-330-D5

Device Description : DD-II 330 Non-Display Doppler, 5MHz vascular probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008296 Catalog Number : DD-330-D8

Device Description : DD-II 330 Non-Display Doppler, 8MHz vascular probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

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