Intio Inc
FDA Regulatory Profile
Intio Inc appears in FDA public data with 1 recall, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0974-2013, Class II) was initiated on February 26, 2013. Its most recent 510(k) clearance was granted on December 16, 2011.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0974-2013 | Class II | INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM | February 26, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K113541 | CLEARSTART SVM SYSTEM | December 16, 2011 |