Intel-GE Care Innovations LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2442-2018 | Class II | Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobil | December 6, 2017 |
| Z-1374-2013 | Class II | QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (mo | April 4, 2013 |
| Z-1375-2013 | Class II | QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of a | April 4, 2013 |
| Z-0877-2013 | Class II | QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended | December 16, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K131585 | INTEL-GE CARE INNOVATIONS QUIETCARE | October 8, 2013 |
| K130821 | INTEL-GE CARE INNOVATIONS CONNECT RCM | August 9, 2013 |
| K130290 | MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE | June 4, 2013 |