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FDA 510(k)

OMNI III PATIENT MONITOR

K-Number: K101052 · 2010-08-11

ApplicantInfinium Medical
Decision Date2010-08-11
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMNI III 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 2010-08-11 under 510(k) number K101052. 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 III PATIENT MONITOR?

OMNI III PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2010-08-11. The listed applicant is Infinium Medical. The 510(k) number is K101052.

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

OMNI III PATIENT MONITOR received FDA 510(k) clearance on 2010-08-11, under 510(k) number K101052.

Who is the listed applicant for OMNI III 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 III PATIENT MONITOR?

The FDA product code for OMNI III 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.

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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 MONITORK103737OMNI II PATIENT MONITORK103268OMNI EXPRESS

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.

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