The following data is part of a premarket notification filed by Lifeline Systems, Inc. with the FDA for Lifeline(r) Personal Response System.
| Device ID | K914103 |
| 510k Number | K914103 |
| Device Name: | LIFELINE(R) PERSONAL RESPONSE SYSTEM |
| Classification | System, Communication, Powered |
| Applicant | LIFELINE SYSTEMS, INC. 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A Sinclair LIFELINE SYSTEMS, INC. 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | ILQ |
| CFR Regulation Number | 890.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-12 |
| Decision Date | 1991-09-27 |