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FDA 510(k)

CARDIO TRACE ELECTRODE

K-Number: K832429 · 1984-05-09

ApplicantPoly-Med Splint Co.
Decision Date1984-05-09
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO TRACE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Poly-Med Splint Co.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K832429. 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 CARDIO TRACE ELECTRODE?

CARDIO TRACE ELECTRODE is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Poly-Med Splint Co.. The 510(k) number is K832429.

When did CARDIO TRACE ELECTRODE receive FDA 510(k) clearance?

CARDIO TRACE ELECTRODE received FDA 510(k) clearance on 1984-05-09, under 510(k) number K832429.

Who is the listed applicant for CARDIO TRACE ELECTRODE?

The FDA 510(k) record lists Poly-Med Splint Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIO TRACE ELECTRODE?

The FDA product code for CARDIO TRACE 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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