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Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K120132

by Philips Medical Systems

Identifiers

510(k) Number
K120132 FDA 510(k)
FDA Product Code
DXN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Suresigns VS3 and VS4 are vital signs monitors designed to measure and display patient vital signs. These devices provide automated delivery of vital signs data from bedside monitors to the hospital's electronic health record (EHR), supporting point-of-care documentation.

The devices are supplied by Philips Medical Systems and were cleared through the FDA 510(k) process under K120132 with product code DXN. They are intended for use in clinical settings where vital sign monitoring is required, as indicated by their classification and authorization.

Frequently asked questions

What are the Suresigns VS3 and VS4 vital signs monitors used for?

The Suresigns VS3 and VS4 vital signs monitors are designed to measure and display patient vital signs, providing automated delivery of this data from bedside monitors to the hospital's electronic health record system to support point-of-care documentation in clinical settings.

How are the Suresigns VS3 and VS4 vital signs monitors supplied and by whom?

The Suresigns VS3 and VS4 vital signs monitors are supplied by Philips Medical Systems, as indicated in the manufacturer and applicant fields of the device authorization record.

What regulatory pathway was used for the Suresigns VS3 and VS4 vital signs monitors?

The Suresigns VS3 and VS4 vital signs monitors were cleared through the FDA 510(k) process under submission number K120132, which determined them to be substantially equivalent to a legally marketed predicate device.

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. Sources consulted: SureSigns VS4 Vital signs monitor - Philips, Philips - SureSigns VS3 Vital signs monitor - Philips, PDF SureSigns VS3 - Philips, SureSigns VS4 Vital signs monitor - Philips

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems

Sources (1)

  • FDA 510(k) K120132 24 fields · synced Oct 6, 2026