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

    PRIME PCA AND PCA/CONTINUOUS SYSTEMS

    K Number: K920637 · Decision Jan 15, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    30
    Applicant Total
    2
    Review Days
    338

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    Basic Information

    Device Name
    PRIME PCA AND PCA/CONTINUOUS SYSTEMS
    K Number
    K920637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prime Medical Products, Inc.
    Date Received
    February 12, 1992
    Decision Date
    January 15, 1993
    Product Code
    MEA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MEA Pump, Infusion, Pca

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    Other Clearances by Prime Medical Products, Inc.

    K Number Device Name
    K914148 PRIME CADI-120