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FDA 510(k)

ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR

K-Number: K021174 · 2003-04-29

ApplicantImagyn Surgical
Decision Date2003-04-29
Product CodeDSB
Advisory CommitteeCV
DecisionUnknown

Device Summary

ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Imagyn Surgical. It received FDA 510(k) clearance on 2003-04-29 under 510(k) number K021174. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR?

ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR is a medical device that received FDA 510(k) clearance on 2003-04-29. The listed applicant is Imagyn Surgical. The 510(k) number is K021174.

When did ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR receive FDA 510(k) clearance?

ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR received FDA 510(k) clearance on 2003-04-29, under 510(k) number K021174.

Who is the listed applicant for ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR?

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

What is the FDA product code for ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR?

The FDA product code for ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR is DSB.

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 Imagyn Surgical as applicant

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Related Devices (Code: DSB)

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.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, 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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