CONVERTER UNIT FOR ECG TRACE DISPLAY

Electrocardiograph

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Converter Unit For Ecg Trace Display.

Pre-market Notification Details

Device IDK830566
510k NumberK830566
Device Name:CONVERTER UNIT FOR ECG TRACE DISPLAY
ClassificationElectrocardiograph
Applicant HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-23
Decision Date1983-05-25

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