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510(k) Data Aggregation

    K Number
    K250135

    Validate with FDA (Live)

    Date Cleared
    2026-01-16

    (364 days)

    Product Code
    Regulation Number
    870.2300
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The WAVE Clinical Platform is software intended to route, store, and display data, alarms, results and diagnostic information from medical devices, Electronic Medical Records (EMR), and Clinical Information Systems (CIS). The WAVE Clinical Platform is a remote monitoring platform that displays physiological data, waveforms, alarms, results, diagnostic and operational information routed through the platform from devices and systems using supported protocols. The WAVE Clinical Platform is intended for use in hospital and hospital type environments or where clinical consultations are needed. The WAVE Clinical Platform is intended to be used by healthcare professionals for the following purposes:

    • To remotely consult regarding patients' conditions and statuses;
    • To remotely review other standard or critical patient and operational data, waveforms, alarms, and results to utilize this information to aid in clinical decisions.

    Warning: The WAVE Clinical Platform is intended to supplement and not replace any part of the hospital's device monitoring or electronic data management systems. Do not rely on the WAVE Clinical Platform product as the sole source of alarms.

    Device Description

    The WAVE Clinical Platform is a remote monitoring platform that displays physiological data, waveforms, alarms, results, diagnostic and operational information routed through the platform from devices and systems using supported protocols. The WAVE Clinical Platform can also route and forward this data to third party systems.

    The WAVE Clinical Platform can utilize the hospital's existing network and hardware for installation and display on any device that is web-enabled. The WAVE Clinical Platform does not control any of the medical devices or systems it is connected with.

    Medical devices and information systems are the predominant sources of data used in the WAVE applications. Data sources such as multi-parameter patient monitors, telemetry transmitters, vital sign monitors, ventilators, anesthesia machines, oximeters, hemodynamic monitors, oxygen saturation monitors, capnography monitors, sedation monitors, nurse call systems, smartphone mobile applications, smart beds, precision locating systems, cameras, variability indexes, hospital information systems, clinical information systems, electronic medical record systems, lab information systems, order systems, fluid delivery systems, medication delivery systems, infusion systems, clinical deterioration algorithm derivatives, gateway servers, etc. provide digital outputs acquired by WAVE and by Medical Device Data Systems that then transfer the data to WAVE.

    AI/ML Overview

    N/A

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