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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 K850860
Device Name AXON II BRAND OF DUAL CHANNEL TENS
Applicant
Cassandra Electronics Corp.
P.O. Box 21067
Minneapolis,  MN  55421
Applicant Contact JAMES R ARDITO
Correspondent
Cassandra Electronics Corp.
P.O. Box 21067
Minneapolis,  MN  55421
Correspondent Contact JAMES R ARDITO
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/01/1985
Decision Date 05/31/1985
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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