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 - 00852785008302 Catalog Number : DD-330R-D2

Device Description : DD-II 330R Non-display Doppler with recharger, 2MHz obstetrical probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008319 Catalog Number : DD-330R-D2W

Device Description : DD-II 330R Non-display Doppler with recharger, 2MHz waterproof obstetrical probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008326 Catalog Number : DD-330R-D3

Device Description : DD-II 330R Non-display Doppler with recharger, 3MHz obstetrical probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008333 Catalog Number : DD-330R-D3W

Device Description : DD-II 330R Non-display Doppler with recharger, 3MHz waterproof obstetrical probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008340 Catalog Number : DD-330R-D5

Device Description : DD-II 330R Non-display Doppler with recharger, 5MHz vascular probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008357 Catalog Number : DD-330R-D8

Device Description : DD-II 330R Non-display Doppler with recharger, 8MHz vascular probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008364 Catalog Number : DD-770-D2

Device Description : DD-II 770 Display Digital Doppler, 2MHz obstetrical probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008371 Catalog Number : DD-770-D2W

Device Description : DD-II 770 Display Digital Doppler, 2MHz waterproof obstetrical probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008388 Catalog Number : DD-770-D3

Device Description : DD-II 770 Display Digital Doppler, 3MHz obstetrical probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

DigiDop - 00852785008395 Catalog Number : DD-770-D3W

Device Description : DD-II 770 Display Digital Doppler, 3MHz waterproof obstetrical probe

Device Class : 2

Duns Number: 078686903

Premarket Exempt : No

Product Code : LXE

Prescription Use : Yes

Device Count : 1

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