The following data is part of a premarket notification filed by Acare Technology Co., Ltd. with the FDA for Acare Suction Unit.
| Device ID | K182950 |
| 510k Number | K182950 |
| Device Name: | Acare Suction Unit |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | Acare Technology Co., Ltd. 5f-4, No.24, Wuquan 2nd Rd, Xinzhuang Dist. New Taipei City, TW 242 |
| Contact | Kevin Tsai |
| Correspondent | Ming-yie Jan RusCert Technology Co., Ltd. 8F.-2, No.21, Sec. 6, Zhongxiao E. Rd., Nangang Dist. Taipei City, TW 115 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-23 |
| Decision Date | 2019-08-23 |