Clearance Summary
One Mum Pumpset received FDA 510(k) clearance under submission number K172067, sponsored by Ardo Medical AG. 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 2017-11-29.
- Submission: K172067
- Applicant / Sponsor: Ardo Medical AG
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2017-11-29
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.