ARRHYTHMIA FUNCTION BLOCK

Detector And Alarm, Arrhythmia

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Arrhythmia Function Block.

Pre-market Notification Details

Device IDK811581
510k NumberK811581
Device Name:ARRHYTHMIA FUNCTION BLOCK
ClassificationDetector And Alarm, Arrhythmia
Applicant HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-05
Decision Date1981-08-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.