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

    PREEMICARE NEBUTECH NEBULIZER SYSTEM

    K Number: K896375 · Decision Oct 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    9
    Review Days
    357

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    Basic Information

    Device Name
    PREEMICARE NEBUTECH NEBULIZER SYSTEM
    K Number
    K896375
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Preemicare Corp.
    Date Received
    November 6, 1989
    Decision Date
    October 29, 1990
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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    K893624 PREEMICARE MODEL 2500 TRANSPORT WARMER
    K891674 NEONATAL ENVIRONMENTAL MONITOR, MODEL 275
    K885350 PREEMICARE SERIES 2000 INFANT WARMER
    K884133 PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP
    K881476 PREEMICARE MODEL D1-X1, SERIES 3000