Cleared Traditional

Cadwell Bolt Software

K190760 · Cadwell Industries, Inc. · Neurology

Nov 2019

Decision

243d

Days

Class 2

Risk

About This 510(k) Submission

K190760 is an FDA 510(k) clearance for the Cadwell Bolt Software, a Non-normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLT), submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on November 23, 2019, 243 days after receiving the submission on March 25, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K190760 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2019
Decision Date	November 23, 2019
Days to Decision	243 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLT — Non-normalizing Quantitative Electroencephalograph Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.