Clearance Summary
KIDScore D3 received FDA 510(k) clearance under submission number K182798, sponsored by Vitrolife 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 2019-07-19.
- Submission: K182798
- Applicant / Sponsor: Vitrolife A/S
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6195
- Decision date: 2019-07-19
Classification & Regulation
This clearance is catalogued under FDA product code PBH and 21 CFR 884.6195, within the Obstetrics/Gynecology review panel as a Class II device.