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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 K981820
Device Name NEUROMAP
Applicant
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Applicant Contact JEFFREY R MANNION
Correspondent
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Correspondent Contact JEFFREY R MANNION
Regulation Number882.1330
Classification Product Code
GZL  
Date Received05/22/1998
Decision Date 11/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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