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)

OMNI II PATIENT MONITOR

K-Number: K103737 · 2011-06-02

ApplicantInfinium Medical
Decision Date2011-06-02
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMNI II PATIENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Infinium Medical. It received FDA 510(k) clearance on 2011-06-02 under 510(k) number K103737. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI II PATIENT MONITOR?

OMNI II PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2011-06-02. The listed applicant is Infinium Medical. The 510(k) number is K103737.

When did OMNI II PATIENT MONITOR receive FDA 510(k) clearance?

OMNI II PATIENT MONITOR received FDA 510(k) clearance on 2011-06-02, under 510(k) number K103737.

Who is the listed applicant for OMNI II PATIENT MONITOR?

The FDA 510(k) record lists Infinium Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNI II PATIENT MONITOR?

The FDA product code for OMNI II PATIENT MONITOR is MWI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Infinium Medical 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.

K112329OMNI PATIENT MONITORK103268OMNI EXPRESSK101052OMNI III PATIENT MONITOR

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.

↑