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

    ZOLL PROPAQ M

    K Number: K102174 · Decision Sep 15, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    21
    Review Days
    44

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    Basic Information

    Device Name
    ZOLL PROPAQ M
    K Number
    K102174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zoll Medical Corporation, World Wide Headquarters
    Date Received
    August 2, 2010
    Decision Date
    September 15, 2010
    Product Code
    DRT
    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
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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