FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Fully Automatic Blood Pressure Monitor LD-535 & LD-539 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.

Device Description

Fully Automatic Blood Pressure Monitor Model: LD-535 & LD-539

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for an automatic digital blood pressure monitor. It does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications. This document primarily confirms that the device is substantially equivalent to a legally marketed predicate device.

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K Number

K130925

Device Name

AUTOMATIC BLOOD PRESSURE MONITOR

Manufacturer

HONSUN (NANTONG) CO., LTD.

Date Cleared

2013-09-12

(162 days)