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Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)

K193449 Class II Traditional
Decision Date
2020-09-11
Sponsor / Applicant
Guangdong Horigen Mother & Baby Products Co., Ltd.

Technical Specification

510(k) Submission ID K193449
Product Code HGX
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.5160
Decision Date 2020-09-11
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) received FDA 510(k) clearance under submission number K193449, 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 2020-09-11.

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.