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FDA 510(k)

ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR

K-Number: K032491 · 2003-09-04

ApplicantImagyn Medical Technologies, Inc.
Decision Date2003-09-04
Product CodeDSB
Advisory CommitteeCV
DecisionUnknown

Device Summary

ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Imagyn Medical Technologies, Inc.. It received FDA 510(k) clearance on 2003-09-04 under 510(k) number K032491. 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 CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR?

ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR is a medical device that received FDA 510(k) clearance on 2003-09-04. The listed applicant is Imagyn Medical Technologies, Inc.. The 510(k) number is K032491.

When did ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR receive FDA 510(k) clearance?

ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR received FDA 510(k) clearance on 2003-09-04, under 510(k) number K032491.

Who is the listed applicant for ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR?

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

What is the FDA product code for ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR?

The FDA product code for ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR is DSB.

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Other records listing Imagyn Medical Technologies, 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.

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Related Devices (Code: DSB)

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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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