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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electromyograph, diagnostic
510(k) Number K864408
Device Name EMG-1, MOTOR NERVE MONITOR
Applicant
ALGOTEK, INC.
2464 EMBARCADERO WAY
PALO ALTO,  CA  94303
Applicant Contact MAURIZIO LIVERANI
Correspondent
ALGOTEK, INC.
2464 EMBARCADERO WAY
PALO ALTO,  CA  94303
Correspondent Contact MAURIZIO LIVERANI
Regulation Number890.1375
Classification Product Code
IKN  
Date Received11/10/1986
Decision Date 01/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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