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 |
|