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

    CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR

    K Number: K923402 · Decision Dec 30, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    7
    Review Days
    173

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    Basic Information

    Device Name
    CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR
    K Number
    K923402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pro-Tech, Inc.
    Date Received
    July 10, 1992
    Decision Date
    December 30, 1992
    Product Code
    BZQ
    Advisory Committee
    Anesthesiology
    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
    BZQ Monitor, Breathing Frequency

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    Other Clearances by Pro-Tech, Inc.

    K Number Device Name
    K940013 BODY POSITION INDICATOR, MODEL BPI1
    K940015 SNORING MICROPHONE, SM1
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    K924752 FREEDOM OXIMETER/EEG DIGITAL INTERFACE
    K913396 CANNULA STYLE THERMOCOUPLES
    K913395 EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS