Acare Suction Unit
510(k) K182950
Acare Suction Unit is a Class II device made by Acare Technology Co., Ltd., cleared under FDA 510(k) K182950 on 23 Aug 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182950 | Date23 Aug 2019 | StatusActive |
Official records
- FDA 510(k) database K182950
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JCX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4780
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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