OPTOVUE, INC.

Address:2800 Bayview Dr,FREMONT,CA,94538,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

Camera, Ophthalmic, Ac-Powered (HKI) (6) Tomography, Optical Coherence (OBO) (5) Ophthalmoscope, Ac-Powered (HLI) (4)

Premarket Exempt

Yes No

Clear

iFusion - 00858848006209 Catalog Number : 700-49003-004

Device Description : iVue NR for iFusion USCFG 230V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : OBO, HKI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006216 Catalog Number : 700-49007-003

Device Description : iVue NR Complete System iWellness USCFG w/ 120V Table

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006223 Catalog Number : 700-49973-002

Device Description : Assy Scanner iVue NR

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iFusion - 00858848006230 Catalog Number : 700-48363-003

Device Description : iVue NR for iFusion System w/ 120V Table

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : OBO, HKI

Prescription Use : Yes

Device Count : 1

iFusion - 00858848006247 Catalog Number : 700-48371-003

Device Description : iVue NR for iFusion USCFG System w/ 120V Table

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : OBO, HKI

Prescription Use : Yes

Device Count : 1

iCam - 00858848006278 Catalog Number : 700-49517-001

Device Description : iCam Camera Head 5 MP

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

iStand - 00858848006285 Catalog Number : 700-48491-001

Device Description : iStand 2

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iFusion - 00858848006292 Catalog Number : 700-48585-003

Device Description : iVue NR for iFusion System w/ 230V Table

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : OBO, HKI

Prescription Use : Yes

Device Count : 1

iFusion - 00858848006308 Catalog Number : 700-48586-003

Device Description : iVue NR for iFusion USCFG System w/ 230V Table

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : OBO, HKI

Prescription Use : Yes

Device Count : 1

iScan - 00858848006315 Catalog Number : 700-49428-002

Device Description : iVue 500 System

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

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