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FDA 510(k)

SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE

K-Number: K881085 · 1988-04-11

ApplicantContour Electrodes, Inc.
Decision Date1988-04-11
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Contour Electrodes, Inc.. It received FDA 510(k) clearance on 1988-04-11 under 510(k) number K881085. 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 SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE?

SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE is a medical device that received FDA 510(k) clearance on 1988-04-11. The listed applicant is Contour Electrodes, Inc.. The 510(k) number is K881085.

When did SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE receive FDA 510(k) clearance?

SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE received FDA 510(k) clearance on 1988-04-11, under 510(k) number K881085.

Who is the listed applicant for SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE?

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

What is the FDA product code for SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE?

The FDA product code for SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE is DRX.

Related Clinical Trials

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Other records listing Contour Electrodes, Inc. 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.

K900682PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODEK893245L30-LB- INFANT LIMB BANDK871412CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO

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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