PORTABLE DEFIBRILLATOR

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.

Pre-market Notification Details

Device IDK840167
510k NumberK840167
Device Name:PORTABLE DEFIBRILLATOR
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 Received1984-01-16
Decision Date1984-02-04

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