Fluobeam 800 Clinic Imaging Device Used With Fluocase 800 Control System

Parathyroid Autofluorescence Imaging Device

Fluoptics

The following data is part of a De Novo classification by Fluoptics with the FDA for Fluobeam 800 Clinic Imaging Device Used With Fluocase 800 Control System.

Pre-market Notification Details

DeNovo IDDEN170092
Device Name:Fluobeam 800 Clinic Imaging Device Used With Fluocase 800 Control System
ClassificationParathyroid Autofluorescence Imaging Device
Applicant Fluoptics 7 Parvis Louis Neel cs 20050 Grenoble Cedex 9,  FR 38040
ContactOdelie Allard
Product CodeQDG  
CFR Regulation Number878.4550 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGeneral & Plastic Surgery
Classification AdvisoryGeneral & Plastic Surgery
TypeDirect
Date Received2017-12-22
Decision Date2018-11-02
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.