Clearance Summary
EMBRYOSCOPE received FDA 510(k) clearance under submission number K111715, sponsored by Unisense Fertilitech A/S. 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 2011-08-11.
- Submission: K111715
- Applicant / Sponsor: Unisense Fertilitech A/S
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6120
- Decision date: 2011-08-11
Classification & Regulation
This clearance is catalogued under FDA product code MQG and 21 CFR 884.6120, within the Obstetrics/Gynecology review panel as a Class II device.