The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Portable Defibrillator/monitor Ed 425.
| Device ID | K851092 |
| 510k Number | K851092 |
| Device Name: | PORTABLE DEFIBRILLATOR/MONITOR ED 425 |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | HONEYWELL, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
| Contact | Martin Kutik |
| Correspondent | Martin Kutik HONEYWELL, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-19 |
| Decision Date | 1985-04-10 |