LogoFDA 510(k) Search
K Number
K023834
Device Name
HL888
Manufacturer
HEALTH & LIFE CO., LTD.
Date Cleared
2003-01-14

(57 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

Measures automatically human's Systolic , Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.

The intended for use of this over-the-counter device is for adult patients with arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a non-invasive blood pressure measurement system (HL 888). It does not contain specific details about acceptance criteria, a study proving the device meets those criteria, or the methodology referenced in your numbered list.

The letter primarily addresses the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines general compliance requirements but does not provide performance metrics or details of any clinical or technical study conducted to support the claim.

Therefore, I cannot extract the requested information regarding:

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample size used for the test set and the data provenance: Not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications: Not present.
  4. Adjudication method: Not present.
  5. Multi reader multi case (MRMC) comparative effectiveness study: Not present.
  6. Standalone performance: Not present.
  7. Type of ground truth used: Not present.
  8. Sample size for the training set: Not present.
  9. How the ground truth for the training set was established: Not present.

The document is a regulatory communication, not a technical report or study summary.

§ 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).