K192640 is an FDA 510(k) clearance for the Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump. This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Guangzhou Yongyi Industrial Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 30, 2020, 188 days after receiving the submission on September 24, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K192640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2019 |
| Decision Date | March 30, 2020 |
| Days to Decision | 188 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 |