GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

Address:9900 Innovation Drive,Wauwatosa,WI,53226,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, imaging, pulsed doppler, ultrasonic (IYN) (6) System, imaging, pulsed echo, ultrasonic (IYO) (6) Transducer, ultrasonic, diagnostic (ITX) (6) Densitometer, bone (KGI) (4)

Premarket Exempt

Clear

Prodigy - 00840682117098 Catalog Number :

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : KGI

Prescription Use : Yes

Device Count : 1

Prodigy - 00840682117142 Catalog Number :

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : KGI

Prescription Use : Yes

Device Count : 1

LOGIQ - 00840682120159 Catalog Number :

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

LOGIQ - 00840682120173 Catalog Number :

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

Venue - 00840682123815 Catalog Number :

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

LOGIQ E9 - 00840682124324 Catalog Number :

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

LOGIQ - 00840682138260 Catalog Number :

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Prodigy - 00840682138345 Catalog Number :

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : KGI

Prescription Use : Yes

Device Count : 1

Prodigy - 00840682138352 Catalog Number :

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : KGI

Prescription Use : Yes

Device Count : 1

Venue Go - 00840682138840 Catalog Number :

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

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