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510(k) K190760

Cadwell Bolt Software by Cadwell Industries, Inc. — Product Code OLT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2019
Date Received
March 25, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.

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