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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
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