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

    MINIPACK 3100/3000 MODIFICATION

    K Number: K934385 · Decision Aug 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    18
    Review Days
    335

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    Basic Information

    Device Name
    MINIPACK 3100/3000 MODIFICATION
    K Number
    K934385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pace Tech, Inc.
    Date Received
    September 9, 1993
    Decision Date
    August 10, 1994
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by Pace Tech, Inc.

    K Number Device Name
    K951226 VITALMAX 4000/MINIPACK 3100/3000
    K953795 VITALMAX 4100
    K944541 HANDYPACK 911SC
    K945385 VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300
    K925701 MINIPACK 911-STC
    K933624 VITALMAX 4000
    K930559 VITALMAX 800-C
    K912835 MINI-PACK 911 SERIES
    K912880 VITALMAX 510/520
    K913263 VITALMAX 830 SERIES
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