BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MICRON ONE PORTA. ULTRASONIC NEBULIZER

    K Number: K850926 · Decision May 23, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    61
    Applicant Total
    1
    Review Days
    79

    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
    MICRON ONE PORTA. ULTRASONIC NEBULIZER
    K Number
    K850926
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5640
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Endotek Development Laboratories
    Date Received
    March 5, 1985
    Decision Date
    May 23, 1985
    Product Code
    CCQ
    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
    CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

    Similar 510(k) Clearances

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

    EZ SPRAY

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    E-Z SPACER MASK (SMALL)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MDI TUTOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MEDSHIELD/AEROCHAMBER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SALINE SOLUTION- STERILE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all