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

    LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE

    K Number: K011903 · Decision Apr 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    403
    Applicant Total
    3
    Review Days
    298

    Basic Information

    Device Name
    LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE
    K Number
    K011903
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VIVOMETRICS, INC.
    Date Received
    June 18, 2001
    Decision Date
    April 12, 2002
    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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    Other Clearances by VIVOMETRICS, INC.

    K Number Device Name
    K043604 LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE
    K031550 REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE