Clearance Summary
Philips Avent Comfort Single/Twin Electric Breast Pump received FDA 510(k) clearance under submission number K161532, 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 2016-08-29.
- Submission: K161532
- 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: 2016-08-29
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.