Regulatory Insight, Inc
FDA Regulatory Profile
Regulatory Insight, Inc appears in FDA public data with 1 recall, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0753-2016, Class II) was initiated on July 1, 2008. Its most recent 510(k) clearance was granted on September 10, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0753-2016 | Class II | GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of dia | July 1, 2008 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140780 | KEGEL SMART, KEGELSMART PEARL | September 10, 2014 |
| K112505 | ETHEREA | April 6, 2012 |
| K020100 | SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS | March 8, 2002 |
| K020094 | EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 ME | March 8, 2002 |