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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 For The Treatment Of Migraine Headache
510(k) Number K230358
Device Name SAVI Dual (TM) Migraine Therapy
Applicant
Eneura, Inc.
101 W. Dickman St. Suite 900
Baltimore,  MD  21230
Applicant Contact David Rosen
Correspondent
Eneura, Inc.
2690 Pheasant Rd.
Orono,  MN  55331
Correspondent Contact Larry W Getlin
Regulation Number882.5808
Classification Product Code
OKP  
Date Received02/10/2023
Decision Date 05/16/2023
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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