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FDA 510(k)

BODY SIGNAL ECG ELECTRODE

K-Number: K031174 · 2003-07-10

ApplicantWandy Rubber Industrial Co., Ltd.
Decision Date2003-07-10
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BODY SIGNAL ECG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Wandy Rubber Industrial Co., Ltd.. It received FDA 510(k) clearance on 2003-07-10 under 510(k) number K031174. 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 BODY SIGNAL ECG ELECTRODE?

BODY SIGNAL ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 2003-07-10. The listed applicant is Wandy Rubber Industrial Co., Ltd.. The 510(k) number is K031174.

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

BODY SIGNAL ECG ELECTRODE received FDA 510(k) clearance on 2003-07-10, under 510(k) number K031174.

Who is the listed applicant for BODY SIGNAL ECG ELECTRODE?

The FDA 510(k) record lists Wandy Rubber Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BODY SIGNAL ECG ELECTRODE?

The FDA product code for BODY SIGNAL ECG ELECTRODE is DRX.

Related Clinical Trials

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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Other records listing Wandy Rubber Industrial Co., Ltd. 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.

K132998WANDY SELF-ADHESIVE ELECTRODESK002219WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODEK002227WANDY SILICONE CONDUCTIVE RUBBER PAD

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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