K254036
- 510(k) number
- K254036
- Device name
- Novii+ Wireless Patch System
- Applicant
- Datex Ohmeda, Inc. WI · US
- Product code
- HGM — System, Monitoring, Perinatal
- Decision date
- 2026-08-10
- Date received
- 2025-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K254036.pdf
Official FDA record: K254036
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.