K221708 is an FDA 510(k) clearance for the CIMILRE Free-T2 Plus. This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Cimilre Co., Ltd. (Cheonan-Si, KR). The FDA issued a Cleared decision on December 23, 2022, 193 days after receiving the submission on June 13, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K221708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2022 |
| Decision Date | December 23, 2022 |
| Days to Decision | 193 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 |