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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 K934051
Device Name BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)
Applicant
Skylark Device Co., Ltd.
P.O. Box 68-502 Taipei
Taiwan, R.O.C.,  TW
Applicant Contact GEORGE K.C. CHEN
Correspondent
Skylark Device Co., Ltd.
P.O. Box 68-502 Taipei
Taiwan, R.O.C.,  TW
Correspondent Contact GEORGE K.C. CHEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/19/1993
Decision Date 07/11/1994
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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