510(k) K231969
K231969 is an FDA 510(k) premarket notification submitted by Dongguanshi Yiyingmei Technology Co., Ltd. for the device "BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)". The FDA issued a decision of Substantially Equivalent on August 30, 2024. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Dongguanshi Yiyingmei Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2024
- Date Received
- July 3, 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