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Medical Monitor 32HS710S

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K251209

by LG Electronics Inc.

Identifiers

510(k) Number
K251209 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Medical Monitor 32HS710S is a Medical Monitor designed for real-time patient monitoring in clinical settings. It provides continuous vital sign tracking, including parameters such as heart rate, blood pressure, and oxygen saturation, to support patient care and diagnostic assessment.

This device is supplied as a reusable medical monitor, intended for use in hospital or clinical environments. It is regulated under FDA 510(k) clearance (K251209) and MDR compliance, with advisory committee classification under Gastroenterology and Urology. Storage and handling follow standard medical device protocols to ensure reliability and sterility.

Frequently asked questions

Is this device intended for single-use or reusable in clinical settings, and how should it be maintained?

The Medical Monitor (32HS710S) is designed as a reusable device for hospital or clinical environments. Since it is not single-use, proper cleaning, disinfection, and maintenance procedures must follow standard medical device protocols to ensure reliability, sterility, and safe operation between patients. The manufacturer’s instructions should be consulted for specific cleaning and sterilization guidelines.

What vital signs does this monitor track in real-time, and what type of clinical environments is it best suited for?

This device provides continuous monitoring of key vital signs, including heart rate, blood pressure, and oxygen saturation (SpO₂). It is specifically designed for clinical settings such as hospitals, where real-time patient tracking supports care and diagnostic assessments. Its reusable nature makes it ideal for environments where multiple patients require ongoing monitoring.

How is this device regulated, and what does the advisory committee classification (Gastroenterology, Urology) imply about its intended use?

The Medical Monitor (32HS710S) is regulated under FDA 510(k) clearance (K251209) and MDR compliance, meaning it has undergone review for safety and performance. The advisory committee classification under Gastroenterology and Urology (product code GCJ) refers to how the submission was filed with the FDA—it does not indicate the device’s clinical indication. Instead, it categorizes the submission process for regulatory purposes. Clinically, this device is intended for general patient monitoring in hospital settings.

What storage and handling precautions should be taken to ensure the device remains reliable and sterile?

Since this is a reusable medical monitor, storage and handling must adhere to standard medical device protocols to maintain reliability and sterility. This includes keeping the device in a clean, dry environment, protecting it from physical damage, and following manufacturer guidelines for disinfection and maintenance. Proper storage conditions prevent contamination and ensure accurate performance when used for patient monitoring.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
LG Electronics Inc.
FDA Applicant
Lg Electronics.Inc

Sources (2)

  • FDA 510(k) K251209 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026