PORTABLE DEFIBRILLATOR MONITOR 74DRK

Dc-defibrillator, Low-energy, (including Paddles)

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Portable Defibrillator Monitor 74drk.

Pre-market Notification Details

Device IDK831696
510k NumberK831696
Device Name:PORTABLE DEFIBRILLATOR MONITOR 74DRK
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-25
Decision Date1983-11-03

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