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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K201678
Device Name iCE-SG Subcutaneous Electrode Arrays
Applicant
Ice Neurosystems, Inc.
1875 Connecticut Ave. NW, Suite 12117
Washington,  DC  20009
Applicant Contact Allen Waziri
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison C Komiyama
Regulation Number882.1330
Classification Product Code
GZL  
Date Received06/19/2020
Decision Date 03/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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