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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Battery-Powered
510(k) Number K111985
Device Name MYOGUIDE SYSTEM MODEL 8008
Applicant
Intronix Technologies Corp.
611 W. 5th St.
Austin,  TX  78701
Applicant Contact RICHARD VINCINS, CQA, RAC (US,EU)
Correspondent
Intronix Technologies Corp.
611 W. 5th St.
Austin,  TX  78701
Correspondent Contact RICHARD VINCINS, CQA, RAC (US,EU)
Regulation Number868.2775
Classification Product Code
BXN  
Date Received07/12/2011
Decision Date 12/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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