K202045 is an FDA 510(k) clearance for the imani i1. This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Imani Co. (Yongin-Si, KR). The FDA issued a Cleared decision on February 26, 2021, 218 days after receiving the submission on July 23, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K202045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2020 |
| Decision Date | February 26, 2021 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGX - Pump, Breast, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5160 |