De Novo DEN210032

Device
AccuMeasure System
Contact
barry sands
De Novo number
DEN210032
Product code
QTH
Regulation
876.1530
Classification name
endoscopic light-projecting measuring device
Decision
granted (DENG)
Decision date
2022-07-26
Date received
2021-08-09
Classification advisory
Gastroenterology/Urology
Review advisory
Gastroenterology/Urology
Type
Direct

Current FDA Classification#

Product code
QTH
Device name
Endoscopic Light-Projecting Measuring Device
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation
876.1530
Implant
N
Life sustain/support
N