Clearance Summary
Electric Breast Pump received FDA 510(k) clearance under submission number K182413, sponsored by Guangdong Horigen Mother & 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 2019-03-07.
- Submission: K182413
- Applicant / Sponsor: Guangdong Horigen Mother & Baby Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2019-03-07
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.