PORTABLE, BATTERY OPERATED 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, Battery Operated Defibrillator.

Pre-market Notification Details

Device IDK810237
510k NumberK810237
Device Name:PORTABLE, BATTERY OPERATED 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 Received1981-01-28
Decision Date1981-02-19

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