K182819 is an FDA 510(k) clearance for the Decanting Device. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Gcmedica Enterprise Ltd.(Wuxi) (Wuxi, CN). The FDA issued a Cleared decision on December 2, 2019, 424 days after receiving the submission on October 4, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K182819 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2018 |
| Decision Date | December 02, 2019 |
| Days to Decision | 424 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |