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FDA 510(k)

PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE

K-Number: K900682 · 1990-07-31

ApplicantContour Electrodes, Inc.
Decision Date1990-07-31
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Contour Electrodes, Inc.. It received FDA 510(k) clearance on 1990-07-31 under 510(k) number K900682. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE?

PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE is a medical device that received FDA 510(k) clearance on 1990-07-31. The listed applicant is Contour Electrodes, Inc.. The 510(k) number is K900682.

When did PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE receive FDA 510(k) clearance?

PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE received FDA 510(k) clearance on 1990-07-31, under 510(k) number K900682.

Who is the listed applicant for PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE?

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

What is the FDA product code for PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE?

The FDA product code for PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE is DRY.

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Other records listing Contour Electrodes, 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: DRY)

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.

K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems CorporationK202154B-CaptaLivanova Deutschland, GmbHK202557Quantum Workstation 12 EliteSpectrum Medical , Ltd.K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems CorporationK181923Quantum Workstation 12.1Spectrum Medical , Ltd.K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd.

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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