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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K212788
Device Name Seer Home
Applicant
Seer Medical Pty Ltd
Melbourne,  AU 3133
Applicant Contact David Mitchell
Correspondent
Seer Medical Pty Ltd
Melbourne,  AU 3133
Correspondent Contact David Mitchell
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received09/01/2021
Decision Date 06/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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