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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 K912643
Device Name ELECTRODE
Applicant
Skylark Device Co., Ltd.
12 Floor 34, Sec. 3 Chung Shan
N. Rd.
Taipei, Taiwan, R.O.C.,  TW
Applicant Contact CHEN
Correspondent
Skylark Device Co., Ltd.
12 Floor 34, Sec. 3 Chung Shan
N. Rd.
Taipei, Taiwan, R.O.C.,  TW
Correspondent Contact CHEN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/14/1991
Decision Date 02/14/1992
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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