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510(k) K201819

Cadwell Apollo System by Cadwell Industries, Inc. — Product Code GWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2020
Date Received
July 1, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

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Other clearances for product code GWQ

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