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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K882266
Device Name DIGITAL EMG MONITOR MYOTRON 120
Applicant
Ats Co.
3535 Banbury Dr.
Apt. 30
Riverside,  CA  92505
Applicant Contact RUDOLF KREPS
Correspondent
Ats Co.
3535 Banbury Dr.
Apt. 30
Riverside,  CA  92505
Correspondent Contact RUDOLF KREPS
Regulation Number882.5050
Classification Product Code
HCC  
Date Received05/31/1988
Decision Date 08/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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