The following data is part of a premarket notification filed by Lifeline Systems, Inc. with the FDA for Single Bed Arrhythmia Monitor Am500.
| Device ID | K831638 |
| 510k Number | K831638 |
| Device Name: | SINGLE BED ARRHYTHMIA MONITOR AM500 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | LIFELINE SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-23 |
| Decision Date | 1983-11-14 |