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

    BCI 3403 SLEEP SCREENING PULSE OXIMETER

    K Number: K011156 · Decision Jun 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    13
    Review Days
    59

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BCI 3403 SLEEP SCREENING PULSE OXIMETER
    K Number
    K011156
    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
    April 16, 2001
    Decision Date
    June 14, 2001
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DQA), ordered by most recent decision date.

    Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AViTA Pulse Oximeter (SP61)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    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
    K013862 BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM
    K013171 3420 DIGIT PULSE OXIMETER, MODEL 3420
    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. →