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

    SERVO-PAK MOLEL 0030

    K Number: K771510 · Decision Aug 16, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    11

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    Basic Information

    Device Name
    SERVO-PAK MOLEL 0030
    K Number
    K771510
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.1975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Isothermal Systems, Inc.
    Date Received
    August 5, 1977
    Decision Date
    August 16, 1977
    Product Code
    BXA
    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
    BXA Analyzer, Gas, Water Vapor, Gaseous-Phase

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