CADWELL FLEX EEG/PSG

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 Flex Eeg/psg.

Pre-market Notification Details

Device IDK133355
510k NumberK133355
Device Name:CADWELL FLEX EEG/PSG
ClassificationFull-montage Standard Electroencephalograph
Applicant CADWELL INDUSTRIES, INC. 909 N Kellogg St Kennewick,  WA  99336
ContactJohn Cadwell Jr.
CorrespondentJohn Cadwell Jr.
CADWELL INDUSTRIES, INC. 909 N Kellogg St Kennewick,  WA  99336
Product CodeGWQ  
Subsequent Product CodeGWE
Subsequent Product CodeGWL
Subsequent Product CodeOLT
Subsequent Product CodeOLV
Subsequent Product CodeOMC
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-31
Decision Date2014-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840067100585 K133355 000
00840067100080 K133355 000
00840067100073 K133355 000
00840067100066 K133355 000
00840067102824 K133355 000
00840067102817 K133355 000

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