Alpine Biomed Aps
FDA Regulatory Profile
Alpine Biomed Aps 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-1407-2013, Class II) was initiated on April 9, 2013. Its most recent 510(k) clearance was granted on December 12, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1407-2013 | Class II | Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071 | April 9, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140680 | LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM | December 12, 2014 |