Rebiscan, Inc.
FDA Regulatory Profile
Rebiscan, 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-0168-2023, Class II) was initiated on October 3, 2022. Its most recent 510(k) clearance was granted on June 8, 2016.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0168-2023 | Class II | Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalign | October 3, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN130051 | PEDIATRIC VISION SCANNER | June 8, 2016 |