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FDA 510(k)

ECG ELECTRODE SYSTEM

K-Number: K873442 · 1987-11-23

ApplicantHiltrode, Inc.(A/S) Subsidiary Munkenes A/S
Decision Date1987-11-23
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG ELECTRODE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S. It received FDA 510(k) clearance on 1987-11-23 under 510(k) number K873442. 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 ECG ELECTRODE SYSTEM?

ECG ELECTRODE SYSTEM is a medical device that received FDA 510(k) clearance on 1987-11-23. The listed applicant is Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S. The 510(k) number is K873442.

When did ECG ELECTRODE SYSTEM receive FDA 510(k) clearance?

ECG ELECTRODE SYSTEM received FDA 510(k) clearance on 1987-11-23, under 510(k) number K873442.

Who is the listed applicant for ECG ELECTRODE SYSTEM?

The FDA 510(k) record lists Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG ELECTRODE SYSTEM?

The FDA product code for ECG ELECTRODE SYSTEM is DRX.

Related Clinical Trials

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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

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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