Cadwell Bolt Software

Non-normalizing Quantitative Electroencephalograph Software

Cadwell Industries, Inc.

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

Pre-market Notification Details

Device IDK190760
501k NumberK190760
Device Name:Cadwell Bolt Software
ClassificationNon-normalizing Quantitative Electroencephalograph Software
Applicant Cadwell Industries, Inc. 909 N. Kellogg Street Kennewick,  WA  99336
ContactEmily Whitehead
CorrespondentEmily Whitehead
Cadwell Industries, Inc. 909 N. Kellogg Street Kennewick,  WA  99336
Product CodeOLT  
Subsequent Product CodeOMA
Subsequent Product CodeORT
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-25
Decision Date2019-11-23

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