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FDA 510(k)

CONTOUR ELECTRODE

K-Number: K844345 · 1985-01-02

ApplicantHeuristic Medical Systems, Inc.
Decision Date1985-01-02
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONTOUR ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Heuristic Medical Systems, Inc.. It received FDA 510(k) clearance on 1985-01-02 under 510(k) number K844345. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTOUR ELECTRODE?

CONTOUR ELECTRODE is a medical device that received FDA 510(k) clearance on 1985-01-02. The listed applicant is Heuristic Medical Systems, Inc.. The 510(k) number is K844345.

When did CONTOUR ELECTRODE receive FDA 510(k) clearance?

CONTOUR ELECTRODE received FDA 510(k) clearance on 1985-01-02, under 510(k) number K844345.

Who is the listed applicant for CONTOUR ELECTRODE?

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

What is the FDA product code for CONTOUR ELECTRODE?

The FDA product code for CONTOUR ELECTRODE is DRX.

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Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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