FDA 510(k) Application Details - K210199

Device Classification Name	Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph   More FDA Info for this Device
510(K) Number	K210199
Device Name	Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant	Ricoh Company, Ltd. 2-3, Hokuyodai Kanazawa-shi 920-0177 JP Other 510(k) Applications for this Company
Contact	Satoshi Yuuki Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2021
Decision Date	07/02/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review