Clearance Summary
Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) received FDA 510(k) clearance under submission number K232477, sponsored by Jiangxi AOV Maternity & Baby Products Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2024-05-09.
- Submission: K232477
- Applicant / Sponsor: Jiangxi AOV Maternity & Baby Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2024-05-09
Classification & Regulation
This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.