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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 K843175
Device Name NERVE STIMULATOR Q10
Applicant
ACM SYSTEMS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ACM SYSTEMS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2775
Classification Product Code
BXN  
Date Received08/13/1984
Decision Date 08/20/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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