AccuMeasure System
FDA 510(k) clearance DEN210032 · decided 2022-07-26
Clearance details
- K-number
- DEN210032
- Device name
- AccuMeasure System
- Applicant
- RQMIS, Inc.
- Decision
- Unknown
- Date received
- 2021-08-09
- Decision date
- 2022-07-26
- Days to decision
- 351 days
- Clearance type
- Direct
- Product code
- QTH
- Device class
- 2
- Regulation number
- 876.1530
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Amesbury, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch RQMIS
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.