FLUOPTICS

FLUOPTICS

Address:44 rue des berges,GRENOBLE Auvergne-Rhone-Alpes,FR

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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

Confocal Optical Imaging (OWN) (6) Holder, Camera, Surgical (FXR) (1) Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories (QGD) (1) Parathyroid Autofluorescence Imaging Device (QDG) (1) Table And Attachments, Operating-Room (BWN) (1)

Premarket Exempt

No Yes

Clear

FLUOBEAM 800 - B475FB800CLV180 Catalog Number :

Device Class : 2

Duns Number: 260631677

Premarket Exempt : No

Product Code : OWN

Prescription Use : Yes

Device Count : 1

FLUOBEAM 800 - B475FB800CLV190 Catalog Number :

Device Class : 2

Duns Number: 260631677

Premarket Exempt : No

Product Code : OWN

Prescription Use : Yes

Device Count : 1

FLUOBEAM LM - B475FBLM0 Catalog Number :

Device Description : Fluorescence imaging system

Device Class : 1

Duns Number: 260631677

Premarket Exempt : No

Product Code : QGD

Prescription Use : Yes

Device Count : 1

FLUOBEAM LX - B475FBLX0 Catalog Number :

Device Description : Fluorescence imaging system

Device Class : 2

Duns Number: 260631677

Premarket Exempt : No

Product Code : QDG

Prescription Use : Yes

Device Count : 1

FLUOCASE 800 - B475FC800CLV180 Catalog Number :

Device Class : 2

Duns Number: 260631677

Premarket Exempt : No

Product Code : OWN

Prescription Use : Yes

Device Count : 1

FLUOCASE 800 - B475FC800CLV190 Catalog Number :

Device Class : 2

Duns Number: 260631677

Premarket Exempt : No

Product Code : OWN

Prescription Use : Yes

Device Count : 1

FLUOCART - B475FKCL0 Catalog Number :

Device Class : 1

Duns Number: 260631677

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : Yes

Device Count : 1

FLUOBEAM SYSTEM STORED INTO FLUOBOX - B475FXCLV111 Catalog Number :

Device Class : 2

Duns Number: 260631677

Premarket Exempt : No

Product Code : OWN

Prescription Use : No

Device Count : 1

FLUOCLIP - B475LXHO0 Catalog Number :

Device Class : 1

Duns Number: 260631677

Premarket Exempt : No

Product Code : FXR

Prescription Use : Yes

Device Count : 1

PHOTONVUE - B475PVUEC0A1V100 Catalog Number :

Device Description : optical head

Device Class : 2

Duns Number: 260631677

Premarket Exempt : No

Product Code : OWN

Prescription Use : Yes

Device Count : 1

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