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

    IN-THE NEBULIZER

    K Number: K900470 · Decision May 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    33
    Review Days
    107

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    IN-THE NEBULIZER
    K Number
    K900470
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Hudson Oxygen Therapy Sales Co.
    Date Received
    January 31, 1990
    Decision Date
    May 18, 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)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CAF), ordered by most recent decision date.

    FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    eRapid with eTrack System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Mesh Nebulizer (H6)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Portable mesh nebulizer (JM821)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HeroTracker Sense

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Hudson Oxygen Therapy Sales Co.

    K Number Device Name
    K902062 PEEP VALVE
    K900783 MDI ADAPTOR
    K895589 MANUAL RESUSCITATOR
    K896136 INFANT C.P.A.P. MONITOR
    K895231 CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
    K895747 VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR
    K890035 BACTERIA FILTER
    K870895 NO. 1552, VALVED VENTI-COMP
    K871157 C.P.A.P. NASAL CANNULA
    K870138 1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE
    Search all 33 clearances from Hudson Oxygen Therapy Sales Co. →