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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K931925
Device Name TPK CUTANEOUS ELECTRODE
Applicant
Staodyne, Inc.
1225 Florida Ave.
P.O. Box 1379
Longmont,  CO  80502
Applicant Contact THOMAS W ROBIRDS
Correspondent
Staodyne, Inc.
1225 Florida Ave.
P.O. Box 1379
Longmont,  CO  80502
Correspondent Contact THOMAS W ROBIRDS
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/16/1993
Decision Date 08/16/1993
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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