PORTABLE DEFIBRILLATOR/MONITOR ED 425

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 Ed 425.

Pre-market Notification Details

Device IDK851092
510k NumberK851092
Device Name:PORTABLE DEFIBRILLATOR/MONITOR ED 425
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant HONEYWELL, INC. ONE CAMPUS DR. Pleasantville,  NY  10570
ContactMartin Kutik
CorrespondentMartin Kutik
HONEYWELL, INC. ONE CAMPUS DR. Pleasantville,  NY  10570
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-19
Decision Date1985-04-10

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