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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reduced- Montage Standard Electroencephalograph
510(k) Number K242930
Device Name Natus BrainWatch System
Applicant
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville,  CA L6H 5S1
Applicant Contact Behsa Khoshnevis
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number882.1400
Classification Product Code
OMC  
Subsequent Product Code
GXY  
Date Received09/24/2024
Decision Date 11/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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