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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
510(k) Number K182950
Device Name Acare Suction Unit
Applicant
Acare Technology Co., Ltd.
5f-4, #24, Wuquan 2nd Rd., Xinzhuang Dist.
New Taipei City,  TW 242
Applicant Contact Kevin Tsai
Correspondent
Ruscert Technology Co., Ltd.
8f.-2, #21, Sec. 6, Zhongxiao E. Rd., Nangang Dist.
Taipei City,  TW 115
Correspondent Contact Ming-Yie Jan
Regulation Number878.4780
Classification Product Code
JCX  
Date Received10/23/2018
Decision Date 08/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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