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FDA 510(k)

MONOTRODE CUTANEOUS ELECTRODE

K-Number: K915864 · 1993-07-21

ApplicantHenley Intl.
Decision Date1993-07-21
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MONOTRODE CUTANEOUS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1993-07-21 under 510(k) number K915864. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOTRODE CUTANEOUS ELECTRODE?

MONOTRODE CUTANEOUS ELECTRODE is a medical device that received FDA 510(k) clearance on 1993-07-21. The listed applicant is Henley Intl.. The 510(k) number is K915864.

When did MONOTRODE CUTANEOUS ELECTRODE receive FDA 510(k) clearance?

MONOTRODE CUTANEOUS ELECTRODE received FDA 510(k) clearance on 1993-07-21, under 510(k) number K915864.

Who is the listed applicant for MONOTRODE CUTANEOUS ELECTRODE?

The FDA 510(k) record lists Henley Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOTRODE CUTANEOUS ELECTRODE?

The FDA product code for MONOTRODE CUTANEOUS ELECTRODE is GXY.

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Other records listing Henley Intl. 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.

K943449NEUROLOGICAL DIAGNOSTIC DEVICESK926278STAIR CLIMBERK926279UPPER BODY EXERCISERK926287EXERCISE BICYCLEK926314HYDRA FITNESS MODEL 311 TOTAL POWERK926313COMPUTERIZED TESTING AND EXERCISE SYSTEMS

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Related Devices (Code: GXY)

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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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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