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FDA 510(k)

MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR

K-Number: K072516 · 2007-10-18

ApplicantMidmark Diagnostics Group
Decision Date2007-10-18
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Midmark Diagnostics Group. It received FDA 510(k) clearance on 2007-10-18 under 510(k) number K072516. 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 MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR?

MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR is a medical device that received FDA 510(k) clearance on 2007-10-18. The listed applicant is Midmark Diagnostics Group. The 510(k) number is K072516.

When did MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR receive FDA 510(k) clearance?

MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR received FDA 510(k) clearance on 2007-10-18, under 510(k) number K072516.

Who is the listed applicant for MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR?

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

What is the FDA product code for MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR?

The FDA product code for MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS 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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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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