BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D

    K Number: K090671 · Decision Jun 11, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    12
    Review Days
    90

    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
    PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D
    K Number
    K090671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contec Medical System Co., Ltd.
    Date Received
    March 13, 2009
    Decision Date
    June 11, 2009
    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 Contec Medical System Co., Ltd.

    K Number Device Name
    K180837 CONTEC Oxygen Concentrator
    K131900 CONTEC ELECTROCARDIOGRAPH
    K101273 DYNAMIC ECG SYSTEM MODEL TLC5000
    K110156 AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,
    K101692 PATIENT MONITOR
    K110774 ELECTRONIC SPHYGMOMANOMETER
    K101127 PATIENT MONITOR, MODEL PM50
    K090936 SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A
    K082480 CONTEC POCKET FETAL DOPPLER
    K082641 FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
    Search all 12 clearances from Contec Medical System Co., Ltd. →