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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extracranial Positional System For A Transcranial Magnetic Stimulation System
510(k) Number K251927
Device Name Zeta Navigation System (ZNS131-US)
Applicant
Zeta Surgical, Inc.
280 Summer St.
Floor 7
Boston,  MA  02210
Applicant Contact Hieu Le Mau
Correspondent
Zeta Surgical, Inc.
280 Summer St.
Floor 7
Boston,  MA  02210
Correspondent Contact Hieu Le Mau
Regulation Number882.4560
Classification Product Code
SGE  
Subsequent Product Code
QFF  
Date Received06/23/2025
Decision Date 10/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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