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

    PULSE OXIMETER CMS50EW

    K Number: K141362 · Decision Apr 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    12
    Review Days
    335

    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 CMS50EW
    K Number
    K141362
    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 Systems Co.,Ltd
    Date Received
    May 23, 2014
    Decision Date
    April 23, 2015
    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 Systems Co.,Ltd

    K Number Device Name
    K232893 Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
    K232895 B-Ultrasound Diagnostic System
    K232908 Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)
    K220245 Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
    K202757 CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
    K201980 Infrared Thermometer
    K171360 CONTEC™ Electrocardiograph
    K170856 CMS600P2 B-Ultrasound Diagnostic System
    K170954 Portable ECG Monitor
    K152863 Portable ECG Monitor
    Search all 12 clearances from Contec Medical Systems Co.,Ltd →