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 |