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

    BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM

    K Number: K013862 · Decision Feb 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    13
    Review Days
    92

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    Basic Information

    Device Name
    BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM
    K Number
    K013862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bci, Inc.
    Date Received
    November 21, 2001
    Decision Date
    February 21, 2002
    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 Bci, Inc.

    K Number Device Name
    K030407 ADVISOR, MODEL 9200
    K031742 BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER
    K020739 BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR
    K020350 BCI 3180 PULSE OXIMETER
    K013171 3420 DIGIT PULSE OXIMETER, MODEL 3420
    K011156 BCI 3403 SLEEP SCREENING PULSE OXIMETER
    K010770 BCI ADVISOR VITAL SIGNS MONITOR (9200)
    K011177 BCI ADVISOR VITAL SIGNS MONITOR (9200)
    K001770 BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A
    K944121 SHARPS CONTAINER 18 GALLON
    Search all 13 clearances from Bci, Inc. →