Clearance Summary
Philips Avent Single/Double electric breast pump Advanced received FDA 510(k) clearance under submission number K201381, sponsored by Philips Consumer Lifestyle - Innovation Site Eindhoven. 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 2020-10-01.
- Submission: K201381
- Applicant / Sponsor: Philips Consumer Lifestyle - Innovation Site Eindhoven
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2020-10-01
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.