Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Novii+ Wireless Patch System

K-Number: K254036 · 2026-08-10

ApplicantDatex Ohmeda, Inc.
Decision Date2026-08-10
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Novii+ Wireless Patch System is the device name listed in this FDA 510(k) record. The listed applicant is Datex Ohmeda, Inc.. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K254036. 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 2026-08-10. The listed applicant is Datex Ohmeda, Inc.. The 510(k) number is K254036.

When did Novii+ Wireless Patch System receive FDA 510(k) clearance?

Novii+ Wireless Patch System received FDA 510(k) clearance on 2026-08-10, under 510(k) number K254036.

Who is the listed applicant for Novii+ Wireless Patch System?

The FDA 510(k) record lists Datex Ohmeda, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Datex Ohmeda, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)K231964Novii+ Wireless Patch SystemK213867Carestation 750/750cK213553Giraffe Incubator Carestation CS1K213551Giraffe Omnibed Carestation CS1

View all 12 devices →

Related Devices (Code: HGM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)Philips Medizin Systeme Boeblingen GmbH

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.

↑