K193449 is an FDA 510(k) clearance for the Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01). This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Guangdong Horigen Mother & Baby Products Co., Ltd. (Shantou, CN). The FDA issued a Cleared decision on September 11, 2020, 273 days after receiving the submission on December 13, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K193449 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2019 |
| Decision Date | September 11, 2020 |
| Days to Decision | 273 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 |