Clearance Summary
Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 received FDA 510(k) clearance under submission number K203383, sponsored by Philips Consumer Lifestyle - Innovation Site Eindhoven. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2020-12-15.
- Submission: K203383
- Applicant / Sponsor: Philips Consumer Lifestyle - Innovation Site Eindhoven
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2020-12-15
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.