OEC MEDICAL SYSTEMS, INC.

Address:384 N WRIGHT BROTHERS DR,SALT LAKE CITY,UT,84116,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

Image-intensified fluoroscopic x-ray system, mobile (OXO) (4) Interventional fluoroscopic x-ray system (OWB) (4) System, x-ray, fluoroscopic, image-intensified (JAA) (4)

Premarket Exempt

Clear

OEC - 00195278096944 Catalog Number : 00195278096944

Device Description : MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC 3D

Device Class : 2

Duns Number: 085305274

Premarket Exempt : No

Product Code : OWB, JAA, OXO

Prescription Use : No

Device Count : 1

OEC - 00840682114301 Catalog Number :

Device Class : 2

Duns Number: 085305274

Premarket Exempt : No

Product Code : OWB, OXO, JAA

Prescription Use : Yes

Device Count : 1

OEC - 00840682114349 Catalog Number :

Device Class : 2

Duns Number: 085305274

Premarket Exempt : No

Product Code : OWB, JAA, OXO

Prescription Use : Yes

Device Count : 1

OEC - 00840682121729 Catalog Number : 00840682121729

Device Description : MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC ELITE

Device Class : 2

Duns Number: 085305274

Premarket Exempt : No

Product Code : JAA, OXO, OWB

Prescription Use : No

Device Count : 1

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