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

    PULSE OXIMETER ADAPTER CABLES

    K Number: K052544 · Decision Sep 29, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    7
    Review Days
    379

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    Basic Information

    Device Name
    PULSE OXIMETER ADAPTER CABLES
    K Number
    K052544
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American I.V. Products, Inc.
    Date Received
    September 15, 2005
    Decision Date
    September 29, 2006
    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 American I.V. Products, Inc.

    K Number Device Name
    K120209 PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE
    K070232 ECG CABLES, TRUNK AND PATIENT LEAD WIRES
    K070342 CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413
    K040392 TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
    K040819 TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
    K032789 REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469