Novii+ Wireless Patch System— 510(k) K231964

Substantially Equivalent

Datex Ohmeda

FDA 510(k) clearance K231964 for Novii+ Wireless Patch System, Substantially Equivalent on 2023-12-08. Applicant: Datex Ohmeda.

Clearance details

Applicant: Datex Ohmeda
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2023-07-03
Decision date: 2023-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wauwatosa, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.