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

    SPIROMETRICS MODEL 2500 FLOWMATE(TM)

    K Number: K863953 · Decision Jan 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    11
    Review Days
    97

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    Basic Information

    Device Name
    SPIROMETRICS MODEL 2500 FLOWMATE(TM)
    K Number
    K863953
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1900
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Spirometrics, Inc.
    Date Received
    October 10, 1986
    Decision Date
    January 15, 1987
    Product Code
    BZM
    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
    BZM Calculator, Pulmonary Function Interpretor (Diagnostic)

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    Other Clearances by Spirometrics, Inc.

    K Number Device Name
    K915059 PEAK FLOW MONITOR
    K911358 CMD/DLCO DIAGNOSTIC SPIROMETER
    K900322 CO/CMD-1
    K901057 SPIROMETRICS MODEL 2600 MIRO SPIROMETER
    K900673 SERIAL FLOW
    K884464 SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR
    K884465 SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)
    K850045 SPIROMETRICS 2453 & SMI III
    K844333 SPIROMETRICS 2451 & SMI I
    K831497 SPIROMETRICS BREON 2400 & SMI 2400
    Search all 11 clearances from Spirometrics, Inc. →