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FDA 510(k)

Novii+ Wireless Patch System

K-Number: K231964 · 2023-12-08

ApplicantDatex Ohmeda
Decision Date2023-12-08
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Novii+ Wireless Patch System is a medical device manufactured by Datex Ohmeda. It received FDA 510(k) clearance on 2023-12-08 under approval number K231964. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Novii+ Wireless Patch System?

Novii+ Wireless Patch System is a medical device that received FDA 510(k) clearance on 2023-12-08. It is manufactured by Datex Ohmeda. The 510(k) number is K231964.

When was Novii+ Wireless Patch System approved by the FDA?

Novii+ Wireless Patch System received FDA 510(k) clearance on 2023-12-08, under approval number K231964.

What company makes Novii+ Wireless Patch System?

Novii+ Wireless Patch System is manufactured by Datex Ohmeda.

What is the FDA product code for Novii+ Wireless Patch System?

The FDA product code for Novii+ Wireless Patch System is HGM.

Related Clinical Trials

NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07608614 Sleep and Performance RECRUITING NCT07603752 Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and Safety Study RECRUITING NCT04956354 The Use of Wireless Sensors in Neonatal Intensive Care ACTIVE_NOT_RECRUITING NCT06693817 Advanced Wireless Sensors for Neonatal Care in the Delivery Room RECRUITING

Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Related Devices (Code: HGM)

K153580Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. K171178Central Monitoring SystemEdan Instruments, Inc. K171865F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer MonitoringFarus, LLC K161902Meridian M110 Fetal Monitoring SystemMindchild Medical K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3Edan Instruments, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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