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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transcranial Magnetic Stimulator
510(k) Number K220177
Device Name Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
Applicant
Magnus Medical, Inc.
1350 Old Bayshore Highway
Suite 600
Burlingame,  CA  94010
Applicant Contact Brett Wingeier
Correspondent
Magnus Medical, Inc.
1350 Old Bayshore Highway
Suite 600
Burlingame,  CA  94010
Correspondent Contact Susan Noreiga
Regulation Number882.5805
Classification Product Code
OBP  
Subsequent Product Codes
GWF   HAW  
Date Received01/21/2022
Decision Date 09/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03068715
NCT03240692
Reviewed by Third Party No
Combination Product No
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