510(k) K230776
K230776 is an FDA 510(k) premarket notification submitted by Shenzhen Lutejiacheng Technology Co., Ltd. for the device "Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)". The FDA issued a decision of Substantially Equivalent on June 9, 2023. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Shenzhen Lutejiacheng Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2023
- Date Received
- March 21, 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