GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

Address:3030 Ohmeda Drive,MADISON,WI,53718,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) (10) System, imaging, pulsed echo, ultrasonic (IYO) (10) Transducer, ultrasonic, diagnostic (ITX) (10)

Premarket Exempt

No

Clear

Venue - 00195278005830 Catalog Number :

Device Description : Venue R3 MD eDelivery or Physical Upgrade

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : No

Device Count : 1

Venue GO - 00195278005861 Catalog Number :

Device Description : Venue Go R3 MD eDelivery or Physical Upgrade

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : No

Device Count : 1

Venue Fit - 00195278194275 Catalog Number :

Device Description : Venue Fit final Assy.

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : No

Device Count : 1

LOGIQ - 00195278384041 Catalog Number :

Device Description : LOGIQ E10 R3 Console

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

Venue Fit - 00195278513014 Catalog Number :

Device Description : Venue Fit R4 MD either eDelivery or physical

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : No

Device Count : 1

Venue - 00195278516480 Catalog Number :

Device Description : Venue R4 final Assembly

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : No

Device Count : 1

Venue Fit - 00195278516497 Catalog Number :

Device Description : Venue Fit R4 Final Assembly

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

Venue Go - 00195278516510 Catalog Number :

Device Description : Venue Go R4 Final Assembly

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : No

Device Count : 1

Venue - 00195278516534 Catalog Number :

Device Description : Venue R4 MD either eDelivery or physical

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

Venue Go - 00195278516541 Catalog Number :

Device Description : Venue Go R4 MD either eDelivery or physical

Device Class : 2

Duns Number: 078863378

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

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