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) (8) Monitor, Ultrasonic, Nonfetal (JAF) (2)

Premarket Exempt

Clear

DigiDop - 00852785008005 Catalog Number : DD-300-D2

Device Description : DigiDop 300, non-display, 2MHZ OB

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008012 Catalog Number : DD-300-D2W

Device Description : DigiDop 300, non-display, 2MHZ OB WATERPROOF

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008029 Catalog Number : DD-300-D3

Device Description : DigiDop 300, non-display, 3MHZ OB

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008036 Catalog Number : DD-300-D3W

Device Description : DigiDop 300, non-display, 3MHZ OB WATERPROOF

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008043 Catalog Number : DD-300-D5

Device Description : DigiDop 300, non-display, 5MHZ VASCULAR

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008050 Catalog Number : DD-300-D8

Device Description : DigiDop 300, non-display, 8MHZ VASCULAR

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008067 Catalog Number : DD-301-D2

Device Description : DigiDop 301, non-display w recharger, 2MHZ OB

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008074 Catalog Number : DD-301-D2W

Device Description : DigiDop 301, non-display w recharger, 2MHZ OB WATERPROOF

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008081 Catalog Number : DD-301-D3

Device Description : DigiDop 301, non-display w recharger, 3MHZ OB

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008098 Catalog Number : DD-301-D3W

Device Description : DigiDop 301, non-display w recharger, 3MHZ OB WATERPROOF

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

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