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M55 K Karaya Gum Disp. Microtape ECG Electrode, 55

by S & W Medico Teknik

510(k) K884983

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK884983 Date9 Mar 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The M55 K Karaya Gum Disp. Microtape ECG Electrode is a disposable electrode used for electrocardiography (ECG) monitoring. It features a Karaya gum adhesive and microtape design for secure attachment to the patient's skin during ECG procedures.

This single-use electrode is supplied in a size 55 configuration and is classified under product code DRX. It received FDA 510(k) clearance with number K884983 on March 9, 1989, as substantially equivalent to predicate devices for cardiovascular applications.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the M55 K Karaya Gum Disp. Microtape ECG Electrode used for?

    The M55 K Karaya Gum Disp. Microtape ECG Electrode is a disposable electrode specifically designed for electrocardiography (ECG) monitoring procedures. It features a Karaya gum adhesive and microtape design to ensure secure attachment to the patient's skin during ECG monitoring.

  • Is this electrode single-use or reusable?

    This electrode is designed for single-use only. It is supplied in a size 55 configuration and should not be reused to ensure proper adhesion, hygiene, and accurate ECG readings.

  • What are the regulatory approvals for this ECG electrode?

    The M55 K Karaya Gum Disp. Microtape ECG Electrode received FDA 510(k) clearance with number K884983 on March 9, 1989. It was classified as substantially equivalent to predicate devices for cardiovascular applications under product code DRX.

  • How is this electrode supplied and what is its size?

    The electrode is supplied in a size 55 configuration as a disposable unit. It is classified under product code DRX and comes ready for use with its Karaya gum adhesive and microtape design for secure attachment during ECG procedures.