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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source Localization Software For Electroencephalograph Or Magnetoencephalograph
510(k) Number K210199
Device Name RICOH MEG
Applicant
Ricoh Company, Ltd.
2-3, Hokuyodai
Kanazawa-shi,  JP 920-0177
Applicant Contact Satoshi Yuuki
Correspondent
Ricoh Company, Ltd.
2-3, Hokuyodai
Kanazawa-shi,  JP 920-0177
Correspondent Contact Satoshi Yuuki
Regulation Number882.1400
Classification Product Code
OLX  
Subsequent Product Code
OLY  
Date Received01/25/2021
Decision Date 07/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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