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K Number
K021240
Device Name
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200
Manufacturer
EIKON HEALTHCARE DEVICE CORP.
Date Cleared
2002-11-08

(204 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The EIKON automatic digital blood pressure monitor, Model HD-200M / HD-200, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to be 7"-15".

Device Description

EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR HD-200M / HD-200 is a noninvasive blood pressure measurement system.

AI/ML Overview

The provided text is a 510(k) summary for the Eikon Automatic Digital Blood Pressure Monitor, Model HD-200M/HD-200. It does not contain the detailed study information required to fully answer your request.

Specifically, the document does not include:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for the test set or training set.
  • Data provenance (country of origin, retrospective/prospective).
  • Number and qualifications of experts for ground truth establishment.
  • Adjudication method.
  • Information on Multi Reader Multi Case (MRMC) comparative effectiveness studies or the effect size of AI assistance.
  • Details about a standalone (algorithm only) performance study.
  • The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for either training or testing.
  • How ground truth for the training set was established.

The document primarily focuses on the FDA's determination of substantial equivalence for the device based on its intended use as a non-invasive blood pressure measurement system for adults. It lists the device name and indications for use, but does not delve into the specifics of the clinical studies or performance data that would have been submitted to support this claim.

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).