Novii+ Wireless Patch System— 510(k) K231964

Name: FDA 510(k) clearance K231964
Creator: U.S. Food and Drug Administration
Published: 2023-12-08

Substantially Equivalent

Datex Ohmeda

FDA 510(k) clearance K231964 for Novii+ Wireless Patch System, Substantially Equivalent on 2023-12-08. Applicant: Datex Ohmeda. Device class: 2.

Clearance details

Applicant: Datex Ohmeda
Product code: Code HGM
Device class: Class 2
Regulation: 21 CFR 884.2740
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 ↗

Recent devices under product code HGM

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K254036 — Novii+ Wireless Patch System2026-08-10
K253021 — ANNE Maternal2026-02-26
K250777 — Sonicaid Team32025-09-19
K241882 — Fetal & Maternal Monitor (F15A, F15A Air)2025-08-27
K241368 — Sonicaid Team32025-02-03

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K071142 — GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM2007-06-06
K042891 — DATEX-OHMEDA OXY-AFR SENSOR2005-06-29

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.