K231964
- 510(k) number
- K231964
- Device name
- Novii+ Wireless Patch System
- Applicant
- Datex Ohmeda WI · US
- Product code
- HGM — System, Monitoring, Perinatal
- Decision date
- 2023-12-08
- Date received
- 2023-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K231964.pdf
Official FDA record: K231964
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.