Clearance Summary
Novii+ Wireless Patch System received FDA 510(k) clearance under submission number K231964, sponsored by Datex Ohmeda. 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 2023-12-08.
- Submission: K231964
- Applicant / Sponsor: Datex Ohmeda
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2023-12-08
Classification & Regulation
This clearance is catalogued under FDA product code HGM and 21 CFR 884.2740, within the Obstetrics/Gynecology review panel as a Class II device.