Barco NV

Address:35 PRESIDENT KENNEDYPARK,KORTRIJK West-Vlaanderen,BE

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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

Camera, Surgical And Accessories (KQM) (5) DISPLAY, CATHODE-RAY TUBE, MEDICAL (DXJ) (4) Digital pathology display (PZZ) (1)

Premarket Exempt

No Yes

Clear

Barco - 05415334031852 Catalog Number : K9352362

Device Description : MDSC-8255 MNA

Device Class : 1

Duns Number: 371618773

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 1

Barco - 05415334031876 Catalog Number : K9352390

Device Description : MDFC-8232 3HW

Device Class : 1

Duns Number: 371618773

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 1

Barco - 05415334031883 Catalog Number : K9352391

Device Description : MDFC-8232 3SW

Device Class : 1

Duns Number: 371618773

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 1

Arthrex - 05415334033023 Catalog Number : K9352380

Device Description : Surgical color monitor

Device Class : 1

Duns Number: 371618773

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 1

Nexxis OR - 05415334033030 Catalog Number : K9605027

Device Description : NEXXIS SYSTEM X670 CM V3

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : DXJ

Prescription Use : Yes

Device Count : 1

Nexxis OR - 05415334033047 Catalog Number : K9605026

Device Description : NEXXIS SYSTEM X620 CM V3

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : DXJ

Prescription Use : Yes

Device Count : 1

Barco - 05415334033115 Catalog Number : K9352370

Device Description : Surgical color monitor

Device Class : 1

Duns Number: 371618773

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 1

Nexxis OR - 05415334033337 Catalog Number : K9605028

Device Description : NEXXIS SYSTEM X670 CM US V3

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : DXJ

Prescription Use : Yes

Device Count : 1

Barco - 05415334033665 Catalog Number : K9301101A

Device Description : MDPC-8127

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : PZZ

Prescription Use : Yes

Device Count : 1

Nexxis OR - 05415334034259 Catalog Number : K9350204F

Device Description : MNA-440 DEC HDMI V2 INC SFP+ EU

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : DXJ

Prescription Use : Yes

Device Count : 1

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