The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Portable Defibrillator Monitor 74drk.
Device ID | K831696 |
510k Number | K831696 |
Device Name: | PORTABLE DEFIBRILLATOR MONITOR 74DRK |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
Applicant | HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LDD |
CFR Regulation Number | 870.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-25 |
Decision Date | 1983-11-03 |