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, No.24, Wuquan 2nd Rd, Xinzhuang Dist. |
New Taipei City,
TW
242
|
|
Applicant Contact |
Kevin Tsai |
Correspondent |
RusCert Technology Co., Ltd. |
8F.-2, No.21, Sec. 6, Zhongxiao E. Rd., Nangang Dist. |
Taipei City,
TW
115
|
|
Correspondent Contact |
Ming-Yie Jan |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 10/23/2018 |
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
|
|
|