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

    BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005

    K Number: K990956 · Decision Jun 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    10
    Review Days
    84

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    Basic Information

    Device Name
    BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005
    K Number
    K990956
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosensor Corp.
    Date Received
    March 22, 1999
    Decision Date
    June 14, 1999
    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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    K950723 AMBULATORY (HOLTER) RECORDING SYSTEM
    K922027 AMBULATORY (HOLTER) RECORDING, MODIFICATION
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