CADWELL EASY AMBULATORY EEG

Full-montage Standard Electroencephalograph

CADWELL LABORATORIES, INC.

The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Cadwell Easy Ambulatory Eeg.

Pre-market Notification Details

Device IDK946094
510k NumberK946094
Device Name:CADWELL EASY AMBULATORY EEG
ClassificationFull-montage Standard Electroencephalograph
Applicant CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick,  WA  99336
ContactCarlton M Cadwell
CorrespondentCarlton M Cadwell
CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick,  WA  99336
Product CodeGWQ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-14
Decision Date1995-09-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840067100660 K946094 000
00840067100592 K946094 000
00840067100455 K946094 000

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