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

    SPIROMETER 210/211

    K Number: K812039 · Decision Sep 25, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    14
    Review Days
    66

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    Basic Information

    Device Name
    SPIROMETER 210/211
    K Number
    K812039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medix Medical Electronics (U.S.A.), Inc.
    Date Received
    July 21, 1981
    Decision Date
    September 25, 1981
    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 Medix Medical Electronics (U.S.A.), Inc.

    K Number Device Name
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    K853393 INSULIN PUMP INSUMAT 229
    K852433 INFUSAFE 205 CATOLOG NO. 205.000
    K813562 SYRINGE DRIVER 209
    K812041 VENTI-MONITOR MODEL 101
    K812045 INFANT APNEA MONITOR MODEL 100
    K812040 OXYGEN MONITOR 140/141
    K812046 TIDAL VOLUME MONITOR 150
    K812044 RESPIRATION RATE MONITOR 120/121
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