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FDA 510(k)

ECG ELECTRODES APRON

K-Number: K982470 · 1998-10-14

ApplicantTapuz Medical Technology , Ltd.
Decision Date1998-10-14
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG ELECTRODES APRON is the device name listed in this FDA 510(k) record. The listed applicant is Tapuz Medical Technology , Ltd.. It received FDA 510(k) clearance on 1998-10-14 under 510(k) number K982470. 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 ELECTRODES APRON?

ECG ELECTRODES APRON is a medical device that received FDA 510(k) clearance on 1998-10-14. The listed applicant is Tapuz Medical Technology , Ltd.. The 510(k) number is K982470.

When did ECG ELECTRODES APRON receive FDA 510(k) clearance?

ECG ELECTRODES APRON received FDA 510(k) clearance on 1998-10-14, under 510(k) number K982470.

Who is the listed applicant for ECG ELECTRODES APRON?

The FDA 510(k) record lists Tapuz Medical Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG ELECTRODES APRON?

The FDA product code for ECG ELECTRODES APRON 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

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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