Cadwell Zenith System

Full-montage Standard Electroencephalograph

Cadwell Industries, Inc.

The following data is part of a premarket notification filed by Cadwell Industries, Inc. with the FDA for Cadwell Zenith System.

Pre-market Notification Details

Device IDK181466
510k NumberK181466
Device Name:Cadwell Zenith System
ClassificationFull-montage Standard Electroencephalograph
Applicant Cadwell Industries, Inc. 909 North Kellogg Street Kennewick,  WA  99336
ContactAlison Hull
CorrespondentJohn Cadwell
Cadwell Industries, Inc. 909 North Kellogg Street Kennewick,  WA  99336
Product CodeGWQ  
Subsequent Product CodeETN
Subsequent Product CodeGWF
Subsequent Product CodeGYC
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-04
Decision Date2018-09-01
Summary:summary

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