Clearance Summary
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 received FDA 510(k) clearance under submission number K052047, sponsored by Avent America, Inc.. 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 2005-09-22.
- Submission: K052047
- Applicant / Sponsor: Avent America, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2005-09-22
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.