FIMI SRL

FIMI SRL

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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, Digital Image Communications, Radiological (LMD) (8) Camera, Surgical And Accessories (KQM) (2)

Premarket Exempt

Yes

Clear

Barco - 05415334002241 Catalog Number : K9350051

Device Description : MDRC-2321 HNIB

Device Class : 1

Duns Number: 428310874

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

Barco - 05415334002258 Catalog Number : K9350052

Device Description : MDRC-2321 HTIB

Device Class : 1

Duns Number: 428310874

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

Barco - 05415334002272 Catalog Number : K9350054

Device Description : MDRC-2321 STIB

Device Class : 1

Duns Number: 428310874

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

Barco - 05415334002296 Catalog Number : K9352052

Device Description : MDSC-8427 LED

Device Class : 1

Duns Number: 428310874

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 1

Barco - 05415334002302 Catalog Number : K9352053

Device Description : MDSC-8427 12G

Device Class : 1

Duns Number: 428310874

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 1

Barco - 05415334003095 Catalog Number : K9350056

Device Description : MDRC-2324 STIB

Device Class : 1

Duns Number: 428310874

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

Barco - 05415334003101 Catalog Number : K9350070

Device Description : MDRC-2324 HNIB

Device Class : 1

Duns Number: 428310874

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

Barco - 05415334003118 Catalog Number : K9350071

Device Description : MDRC-2324 HTEW

Device Class : 1

Duns Number: 428310874

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

Barco - 05415334003132 Catalog Number : K9350080

Device Description : MDRC-2324 HTIB

Device Class : 1

Duns Number: 428310874

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

Barco - 05415334003149 Catalog Number : K9350081

Device Description : MDRC-2324 HNEW

Device Class : 1

Duns Number: 428310874

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

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