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

    PULSE-OX

    K Number: K863857 · Decision Oct 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    29
    Review Days
    370

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    Basic Information

    Device Name
    PULSE-OX
    K Number
    K863857
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Life Design Systems, Inc.
    Date Received
    October 2, 1986
    Decision Date
    October 7, 1987
    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 Life Design Systems, Inc.

    K Number Device Name
    K913714 MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)
    K885313 HUMIDI-FLEX TM
    K893030 CHILD SIZE - FILTER FLEX (TM)
    K892862 FLEX-CUP PERCUSSOR
    K892221 PULMONARY RESUSCITATOR, MODIFICATION
    K890011 OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING
    K890108 MODIFIED CUSHION-FLEX(TM)
    K884387 CUSHION FLEX(TM)
    K884068 PULMANEX TM (NEO-NATAL SIZE)
    K873179 HEATER WIRE BREATHING CIRCUIT
    Search all 29 clearances from Life Design Systems, Inc. →