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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 K123902
Device Name PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
Applicant
OKTX LLC
7225 S 85TH E AVE.
SUITE 300
TULSA,  OK  74137
Applicant Contact MARY ROSE C REASTON
Correspondent
OKTX LLC
7225 S 85TH E AVE.
SUITE 300
TULSA,  OK  74137
Correspondent Contact MARY ROSE C REASTON
Regulation Number890.1375
Classification Product Code
IKN  
Date Received12/18/2012
Decision Date 09/13/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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