Clearance Summary
Electric breast pump (model: M5) received FDA 510(k) clearance under submission number K223693, sponsored by Shenzhen Lutejiacheng Technology 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 2023-03-09.
- Submission: K223693
- Applicant / Sponsor: Shenzhen Lutejiacheng Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2023-03-09
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.