FDA 510(k) Application Details - K182950

Device Classification Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered   More FDA Info for this Device
510(K) Number	K182950
Device Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant	Acare Technology Co., Ltd. 5f-4, No.24, Wuquan 2nd Rd, Xinzhuang Dist. New Taipei City 242 TW Other 510(k) Applications for this Company
Contact	Kevin Tsai Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	JCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2018
Decision Date	08/23/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review