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FDA 510(k)

PRE-GELLED DISPOS ELECTRODE

K-Number: K832877 · 1983-12-22

ApplicantAdvance Tech Intl.
Decision Date1983-12-22
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRE-GELLED DISPOS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Advance Tech Intl.. It received FDA 510(k) clearance on 1983-12-22 under 510(k) number K832877. 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 PRE-GELLED DISPOS ELECTRODE?

PRE-GELLED DISPOS ELECTRODE is a medical device that received FDA 510(k) clearance on 1983-12-22. The listed applicant is Advance Tech Intl.. The 510(k) number is K832877.

When did PRE-GELLED DISPOS ELECTRODE receive FDA 510(k) clearance?

PRE-GELLED DISPOS ELECTRODE received FDA 510(k) clearance on 1983-12-22, under 510(k) number K832877.

Who is the listed applicant for PRE-GELLED DISPOS ELECTRODE?

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

What is the FDA product code for PRE-GELLED DISPOS ELECTRODE?

The FDA product code for PRE-GELLED DISPOS ELECTRODE 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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