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

    FLEXI-SITE SP02 EAR SENSOR

    K Number: K010718 · Decision Mar 23, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    10
    Applicant Total
    13
    Review Days
    11

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    Basic Information

    Device Name
    FLEXI-SITE SP02 EAR SENSOR
    K Number
    K010718
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2710
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epic Medical Equipment Services, Inc.
    Date Received
    March 12, 2001
    Decision Date
    March 23, 2001
    Product Code
    DPZ
    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
    DPZ Oximeter, Ear

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    Other Clearances by Epic Medical Equipment Services, Inc.

    K Number Device Name
    K012333 FLEXI-SITE SP02 EAR SENSOR
    K002848 SPO2 WRAP SENSOR
    K002223 EPIC SPO2 FINGER SENSOR, MODEL E412-20
    K000831 STAT-SHELL DISPOSABLE SP02 SENSOR
    K992811 TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
    K992211 SPO2 WRAP SENSOR
    K992092 STAT-SHELL DISPOSABLE SPO2 SENSOR
    K990082 EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09
    K970098 E100 SERIES SPO2 SENSORS
    K965172 OXIMETER PRE-AMP CABLE
    Search all 13 clearances from Epic Medical Equipment Services, Inc. →