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Surveyor Patient Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173765

by Mortara Instrument, Inc.

Identifiers

510(k) Number
K173765 FDA 510(k)
FDA Product Code
MHX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1025 FDA 510(k)
Regulation Number
870.1025 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Surveyor Patient Monitor is a physiological patient monitor with arrhythmia detection or alarms, used for monitoring patient physiological parameters. It is classified as a class 2 device. The device is designed to provide comprehensive monitoring of patient vital signs and other physiological parameters.

The Surveyor Patient Monitor is supplied with various features such as a high-resolution display, intuitive touchscreen user interface, and long battery life. It is a portable device with an integrated handle, and its display layout can be configured to show up to 8 waveforms. The device has been authorized with FDA 510K clearance, and its regulation number is 870.1025.

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: MORTARA SURVEYOR USER MANUAL Pdf Download | ManualsLib, Mortara SURVEYOR S12 Patient Monitor Operator's Manual, Mortara Surveyor S12 Patient Monitor - Davis Medical Electronics, Mortara - Surveyor S12 Community, Manuals and Specifications | MedWrench

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mortara Instrument, Inc.

Sources (1)

  • FDA 510(k) K173765 24 fields · synced Sep 22, 2026