Lifeline Systems Company
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1316-2018 | Class II | HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator. | November 13, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K103214 | M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 | December 1, 2010 |
| K914103 | LIFELINE(R) PERSONAL RESPONSE SYSTEM | September 27, 1991 |
| K834441 | BLOOD PRESSURE MONITOR BP600X | May 21, 1984 |
| K831638 | SINGLE BED ARRHYTHMIA MONITOR AM500 | November 14, 1983 |