510(k) K232477
K232477 is an FDA 510(k) premarket notification submitted by Jiangxi AOV Maternity & Baby Products Co., Ltd. for the device "Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)". The FDA issued a decision of Substantially Equivalent on May 9, 2024. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Jiangxi AOV Maternity & Baby Products Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2024
- Date Received
- August 16, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Breast, Powered
- Device Class
- Class II
- Regulation Number
- 884.5160
- Review Panel
- OB
- Submission Type