OPTOVUE, INC.

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

Want to know more about this Organization? Request more information now!

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

Ophthalmoscope, Ac-Powered (HLI) (7) Camera, Ophthalmic, Ac-Powered (HKI) (3) Tomography, Optical Coherence (OBO) (3)

Premarket Exempt

No Yes

Clear

iVue - 00858848006100 Catalog Number : 700-48578-004

Device Description : iVue NR Complete System w/ 230V Table

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006117 Catalog Number : 700-48580-004

Device Description : iVue NR System w/o Laptop 120V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006124 Catalog Number : 700-48581-004

Device Description : iVue NR System w/o Laptop USCFG 120V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006131 Catalog Number : 700-48805-005

Device Description : iVue NR System w/ Laptop 230V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006148 Catalog Number : 700-48806-005

Device Description : iVue NR System w/ Laptop USCFG 230V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006155 Catalog Number : 700-48807-004

Device Description : iVue NR System w/o Laptop 230V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006162 Catalog Number : 700-48808-004

Device Description : iVue NR System w/o Laptop USCFG 230V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iFusion - 00858848006179 Catalog Number : 700-49000-004

Device Description : iVue NR for iFusion 120V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : OBO, HKI

Prescription Use : Yes

Device Count : 1

iFusion - 00858848006186 Catalog Number : 700-49001-004

Device Description : iVue NR for iFusion USCFG 120V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : OBO, HKI

Prescription Use : Yes

Device Count : 1

iFusion - 00858848006193 Catalog Number : 700-49002-004

Device Description : iVue NR for iFusion 230V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : OBO, HKI

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 4 5 7 Next