510(k) DEN210032
- Device
- AccuMeasure System
- Applicant
- RQMIS, Inc.
- 510(k) number
- DEN210032
- Product code
- QTH
- Decision
- Unknown (DENG)
- Decision date
- 2022-07-26
- Date received
- 2021-08-09
- Regulation
- 876.1530
- Classification name
- Endoscopic Light-Projecting Measuring Device
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Barry Sands
- Address
- 110 Haverhill Rd. Suite 524 Amesbury MA US 01913 01913
FDA Registration Numbers#
- 3006161756
- 3042225166
Source Documents#
510(k) summary PDF not indicated by FDA