BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SPIROCAL

    K Number: K791294 · Decision Aug 16, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    7
    Review Days
    37

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    Basic Information

    Device Name
    SPIROCAL
    K Number
    K791294
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2620
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Equilibrated Bio Systems, Inc.
    Date Received
    July 10, 1979
    Decision Date
    August 16, 1979
    Product Code
    BXX
    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
    BXX Calibrator, Pressure, Gas

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