K232477 is an FDA 510(k) clearance for the Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852). This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Jiangxi AOV Maternity & Baby Products Co., Ltd. (Guixi, CN). The FDA issued a Cleared decision on May 9, 2024, 267 days after receiving the submission on August 16, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K232477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2023 |
| Decision Date | May 09, 2024 |
| Days to Decision | 267 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 |