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

    SPACELABS SMART DISCLOSURE SYSTEM

    K Number: K110779 · Decision Apr 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    10
    Review Days
    29

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    Basic Information

    Device Name
    SPACELABS SMART DISCLOSURE SYSTEM
    K Number
    K110779
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spacelabs Healthcare
    Date Received
    March 21, 2011
    Decision Date
    April 19, 2011
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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    K Number Device Name
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    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