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

    Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D

    K Number: K151287 · Decision Jan 6, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    21
    Review Days
    237

    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
    Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
    K Number
    K151287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangdong Biolight Meditech Co., Ltd.
    Date Received
    May 14, 2015
    Decision Date
    January 6, 2016
    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 Guangdong Biolight Meditech Co., Ltd.

    K Number Device Name
    K181919 Patient Monitor
    K170514 Central Monitoring System
    K162234 Truscope Ultra Patient Monitor
    K160349 Electronic Sphygmomanometer
    K153580 Central Monitoring System
    K153135 VITAL SIGNS MONITOR
    K152739 Electronic Thermometer
    K131858 DIGITAL ELECTROCARDIOGRAPH
    K131762 HANDHELD MONITOR
    K131941 FETAL MONITORS
    Search all 21 clearances from Guangdong Biolight Meditech Co., Ltd. →