BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SPACELABS HEALTHCARE TELEMETRY RECEIVER

    K Number: K141156 · Decision Sep 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    10
    Review Days
    127

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    Basic Information

    Device Name
    SPACELABS HEALTHCARE TELEMETRY RECEIVER
    K Number
    K141156
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spacelabs Healthcare
    Date Received
    May 5, 2014
    Decision Date
    September 9, 2014
    Product Code
    MHX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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    Other Clearances by Spacelabs Healthcare

    K Number Device Name
    K150329 elance Vital Signs Monitor, Central Monitor Software
    K122146 XHIBIT CENTRAL STATION, MODEL 96102
    K130112 CAPNO MODULE, 92517
    K121017 CAPNOGRAPHY PAD (92516)
    K112729 BLEASE700/900 SERIES VENTILATORS
    K121480 ARIATELE TELEMETRY TRANSMITTER (96281)
    K113051 SPACELABS ARKON ANESTHESIA WORKSTATION
    K112173 SPEACELABS MULTIGAS MODULE
    K110779 SPACELABS SMART DISCLOSURE SYSTEM