Company ยท US
Lifeline Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2010. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 1, 2010 | K103214 | M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 Lifeline Systems, Inc. | DRG |
| Sep 27, 1991 | K914103 | LIFELINE(R) PERSONAL RESPONSE SYSTEM Lifeline Systems, Inc. | ILQ |
| May 21, 1984 | K834441 | BLOOD PRESSURE MONITOR BP600X Lifeline Systems, Inc. | DXN |
| Nov 14, 1983 | K831638 | SINGLE BED ARRHYTHMIA MONITOR AM500 Lifeline Systems, Inc. | DSI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2017 | Lifeline Systems Company HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator. Terminated |
ILQ | K914103 |
| Oct 1, 2015 | Lifeline Systems, Incorporated Philips GoSafe Mobile Help Button; 7000MHB.
Personal Emergency Response System. Terminated |
ILQ | K914103 |
| Jul 6, 2015 | Lifeline Systems, Incorporated Philips GoSafe Communicator 7000L
Personal emergency response system. Terminated |
ILQ | K914103 |