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FDA 510(k)

FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE

K-Number: K875041 · 1988-01-28

ApplicantLabeltape Meditect, Inc.
Decision Date1988-01-28
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Labeltape Meditect, Inc.. It received FDA 510(k) clearance on 1988-01-28 under 510(k) number K875041. 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 FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE?

FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE is a medical device that received FDA 510(k) clearance on 1988-01-28. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K875041.

When did FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE receive FDA 510(k) clearance?

FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE received FDA 510(k) clearance on 1988-01-28, under 510(k) number K875041.

Who is the listed applicant for FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE?

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

What is the FDA product code for FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE?

The FDA product code for FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE is DRX.

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Other records listing Labeltape Meditect, 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.

K951328LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORDK915333ELECTRODE USING PROMEON RG-60 SERIES GELK914871TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GELK912979HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATIONK902738ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTHK902719SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT

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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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