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

    VITALMAX 510/520

    K Number: K912880 · Decision Nov 14, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    18
    Review Days
    136

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    Basic Information

    Device Name
    VITALMAX 510/520
    K Number
    K912880
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pace Tech, Inc.
    Date Received
    July 1, 1991
    Decision Date
    November 14, 1991
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQA Oximeter

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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
    K934385 MINIPACK 3100/3000 MODIFICATION
    K933624 VITALMAX 4000
    K930559 VITALMAX 800-C
    K912835 MINI-PACK 911 SERIES
    K913263 VITALMAX 830 SERIES
    Search all 18 clearances from Pace Tech, Inc. →