510(k) DEN210032
DEN210032 is an FDA 510(k) premarket notification submitted by RQMIS, Inc. for the device "AccuMeasure System". The FDA issued a decision of De Novo Granted on July 26, 2022. The device falls under product code QTH (Endoscopic Light-Projecting Measuring Device), a Class II device regulated under 21 CFR 876.1530.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 26, 2022
- Date Received
- August 9, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Light-Projecting Measuring Device
- Device Class
- Class II
- Regulation Number
- 876.1530
- Review Panel
- GU
- Submission Type
An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest.