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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name non-normalizing quantitative electroencephalograph software
510(k) Number K192572
Device Name CNS Envision
Applicant
Moberg Research, Inc.
224 S. Maple Street
Ambler,  PA  19002
Applicant Contact Anna Rodriguez
Correspondent
Moberg Research, Inc.
224 S. Maple Street
Ambler,  PA  19002
Correspondent Contact Anna Rodriguez
Regulation Number882.1400
Classification Product Code
OLT  
Date Received09/18/2019
Decision Date 12/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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