The following data is part of a premarket notification filed by Personal Emergency Response System with the FDA for Medical Alert System, Model 2200 & 4400 V/t.
| Device ID | K904796 |
| 510k Number | K904796 |
| Device Name: | MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T |
| Classification | System, Communication, Powered |
| Applicant | PERSONAL EMERGENCY RESPONSE SYSTEM 119 INDUSTRIAL DR. P.O. BOX 431 East Longmeadow, MA 01028 |
| Contact | Andrew Queen |
| Correspondent | Andrew Queen PERSONAL EMERGENCY RESPONSE SYSTEM 119 INDUSTRIAL DR. P.O. BOX 431 East Longmeadow, MA 01028 |
| Product Code | ILQ |
| CFR Regulation Number | 890.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-23 |
| Decision Date | 1990-11-26 |