Simpliscriptor EK 31/101 037 16

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

510(k) Number

K832184 ↗

FDA Product Code

DPS

Device Class

Class II

Regulation

21 CFR Part 870.2340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Servomed Basic Bedside Unit Smv 110TP

  Class II

  FDA 510(k) K840524 Active Cleared 26 Oct 1984

• 2-Channel Recorder

  Class I

  FDA 510(k) K832998 Active Cleared 1 Jun 1984

• Servomed Basic Bedside Unit Sms 108 W/

  Class II

  FDA 510(k) K832026 Active Cleared 26 Oct 1983

• Respiration Monitor

  Class II

  FDA 510(k) K832999 Active Cleared 13 Feb 1984

• Lme Blood Pressure Monitor

  Class II

  FDA 510(k) K832017 Active Cleared 31 Oct 1983

• Servomed Compact Monitor Smk 155-7/101

  Class II

  FDA 510(k) K832025 Active Cleared 22 Mar 1984

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• Is the Simpliscriptor EK 31/101 037 16 designed for single-use or can it be reused in a clinical setting?

  The Simpliscriptor EK 31/101 037 16 is explicitly described as a reusable medical instrument. Since it is intended for use in clinical settings like hospitals and cardiac care units, proper maintenance and calibration are required to ensure accurate and reliable performance over multiple uses. Always follow the manufacturer’s guidelines for cleaning, servicing, and storage to maintain its functionality.

• What types of cardiac conditions can this electrocardiograph help diagnose, and how does it do so?

  The Simpliscriptor EK 31/101 037 16 is designed to record and display the heart’s electrical activity, enabling clinicians to diagnose conditions such as arrhythmias (irregular heart rhythms) and myocardial ischemia (reduced blood flow to the heart muscle). By capturing real-time cardiac rhythms, it provides visual data for evaluating abnormal electrical patterns that may indicate these or other cardiac issues.

• How is this device supplied, and what considerations should be made for its storage and maintenance?

  The Simpliscriptor EK 31/101 037 16 is supplied as a reusable electrocardiograph intended for clinical environments. Since it is not sterile (no sterility information is provided), it requires proper cleaning, calibration, and maintenance to ensure accurate readings. Storage should follow manufacturer recommendations to prevent damage, and regular servicing is essential for long-term reliability, especially in high-use settings like hospitals or cardiac care units.

• What regulatory pathway was followed for FDA clearance, and what does this mean for its use in clinical settings?

  The Simpliscriptor EK 31/101 037 16 was cleared through the FDA’s Traditional 510(k) pathway in 1983 under the Cardiovascular advisory committee, with a clearance decision dated October 31, 1983. This means the device was determined to be substantially equivalent to a legally marketed predicate device at the time, allowing it to be legally marketed in the U.S. for its intended diagnostic use in electrocardiographic evaluations.