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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Nerve Conduction Velocity Measurement
510(k) Number K190536
Device Name Mediracer NCS
Applicant
Mediracer Oy
Rantakatu 4
Oulu,  FI 90100
Applicant Contact Lassi Laitinen
Correspondent
Mediracer Oy
Rantakatu 4
Oulu,  FI 90100
Correspondent Contact Lassi Laitinen
Regulation Number882.1550
Classification Product Code
JXE  
Subsequent Product Code
IKN  
Date Received03/04/2019
Decision Date 09/25/2019
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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