Clearance Summary
Invu by Nuvo received FDA 510(k) clearance under submission number K221046, sponsored by Nuvo- Group , Ltd.. 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 2022-05-06.
- Submission: K221046
- Applicant / Sponsor: Nuvo- Group , Ltd.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2730
- Decision date: 2022-05-06
Classification & Regulation
This clearance is catalogued under FDA product code LQK and 21 CFR 884.2730, within the Obstetrics/Gynecology review panel as a Class II device.