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

    DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER

    K Number: K024235 · Decision Mar 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    12
    Review Days
    84

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    Basic Information

    Device Name
    DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER
    K Number
    K024235
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dolphin Medical, Inc.
    Date Received
    December 23, 2002
    Decision Date
    March 17, 2003
    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 Dolphin Medical, Inc.

    K Number Device Name
    K060524 DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES
    K040380 DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420
    K033876 DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422
    K032947 NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210
    K031465 MODEL 2100 PULSE OXIMETER
    K030629 DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER
    K030952 DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421
    K014218 OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'
    K021959 DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100
    K012989 DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070
    Search all 12 clearances from Dolphin Medical, Inc. →