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

    FREEDOM OXIMETER/EEG DIGITAL INTERFACE

    K Number: K924752 · Decision Sep 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    7
    Review Days
    352

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    Basic Information

    Device Name
    FREEDOM OXIMETER/EEG DIGITAL INTERFACE
    K Number
    K924752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pro-Tech, Inc.
    Date Received
    September 23, 1992
    Decision Date
    September 10, 1993
    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 Pro-Tech, Inc.

    K Number Device Name
    K940013 BODY POSITION INDICATOR, MODEL BPI1
    K940015 SNORING MICROPHONE, SM1
    K940014 PLM SENSOR, MODEL PLM1
    K923402 CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR
    K913396 CANNULA STYLE THERMOCOUPLES
    K913395 EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS