LDS Monitoring Electrode

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

510(k) Number

K821846 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Headstrap

  Class I

  FDA 510(k) K854537 Active Cleared 3 Dec 1985

• Modified Cushion-Flex(Tm)

  Class I

  FDA 510(k) K890108 Active Cleared 24 Jan 1989

• Modification Manual Pulmon Resuscitor/Pulmanex(Tm)

  Class II

  FDA 510(k) K913714 Active Cleared 1 Dec 1992

• Flow Generator for Sleep Apnea, Lds 1500

  Class II

  FDA 510(k) K862448 Active Cleared 14 Nov 1986

• Pulmanex

  Class II

  FDA 510(k) K854037 Active Cleared 1 Nov 1985

• Cushion Flex(Tm)

  Class I

  FDA 510(k) K884387 Active Cleared 17 Nov 1988

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• What is the LDS Monitoring Electrode used for?

  The LDS Monitoring Electrode is designed to attach to the skin and detect electrical activity from the heart. It transmits electrocardiogram (ECG) signals to monitoring systems, enabling clinicians to assess cardiac rhythms and electrical conduction in real time. This makes it essential for patient monitoring in settings like hospitals and cardiac care units.

• Is the LDS Monitoring Electrode reusable or single-use?

  The LDS Monitoring Electrode is explicitly supplied as a reusable device. Unlike single-use electrodes, this model is intended for repeated use in clinical environments, provided proper cleaning and maintenance protocols are followed between applications.

• What regulatory approval does the LDS Monitoring Electrode hold?

  The LDS Monitoring Electrode holds FDA 510(k) clearance under the reference number K821846. It is classified as a Class II device under the product code DRX and was determined to be substantially equivalent to a predicate device by the FDA’s Cardiovascular Advisory Committee in 1982.

• Are there specific storage instructions for the LDS Monitoring Electrode?

  The provided data does not specify detailed storage conditions for the LDS Monitoring Electrode. However, as a reusable device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its functionality and hygiene between uses.

• Can the LDS Monitoring Electrode be used with MRI equipment?

  The available records do not include any information regarding the MRI safety of the LDS Monitoring Electrode. Clinicians should verify compatibility with their specific MRI systems before use, as metallic components or conductive materials may pose risks in magnetic fields.