The following data is part of a premarket notification filed by Lifeline Systems, Inc. with the FDA for M3810a Philips Telemonitoring System With Edevice Bridged130.
| Device ID | K103214 |
| 510k Number | K103214 |
| Device Name: | M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | LIFELINE SYSTEMS, INC. 111 LAWRENCE ST. Framingham, MA 01702 -8156 |
| Contact | Carlos O Acosta |
| Correspondent | Carlos O Acosta LIFELINE SYSTEMS, INC. 111 LAWRENCE ST. Framingham, MA 01702 -8156 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2010-12-01 |
| Summary: | summary |