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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, Transcutaneous, For Pain Relief
510(k) Number K851735
Device Name SYS STIM 206 MODEL ME206
Applicant
Mettler Electronics Corp.
1333 S. Claudina St.
Anaheim,  CA  92805
Applicant Contact ROB FLEMING
Correspondent
Mettler Electronics Corp.
1333 S. Claudina St.
Anaheim,  CA  92805
Correspondent Contact ROB FLEMING
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/25/1985
Decision Date 11/19/1985
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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