Clearance Summary
SCANDINAVIAN IVF SCIENCES AB, HYBASE-1 received FDA 510(k) clearance under submission number K000627, sponsored by Vitrolife AB/Scandinavian Ivf Sciences AB. 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 2000-06-13.
- Submission: K000627
- Applicant / Sponsor: Vitrolife AB/Scandinavian Ivf Sciences AB
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2000-06-13
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.