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

    SCHILLER MODEL SP-100 SPIROVIT(TM)

    K Number: K896120 · Decision Jan 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    10
    Review Days
    77

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    Basic Information

    Device Name
    SCHILLER MODEL SP-100 SPIROVIT(TM)
    K Number
    K896120
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Schiller America, Inc.
    Date Received
    October 24, 1989
    Decision Date
    January 9, 1990
    Product Code
    BZG
    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
    BZG Spirometer, Diagnostic

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    Other Clearances by Schiller America, Inc.

    K Number Device Name
    K973735 MICROVIT MT-100
    K973751 MT-200
    K970879 CARDIOVIT CS-200
    K953396 CARDIOVIT AT-1C, AT-2C
    K954066 MINISCOPE MS-3
    K941462 CARDIOVIT AT-5C
    K946205 CARDIOVIT AT-1, P-80
    K914970 CARDIOVIT CS-100
    K896121 SCHILLER MODEL SP-200 SPIROVIT(TM)