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

    RESPIRIZER

    K Number: K810335 · Decision Mar 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    39

    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
    RESPIRIZER
    K Number
    K810335
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5460
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Respirizer Co., Div. Campillary Systems, Inc.
    Date Received
    February 9, 1981
    Decision Date
    March 20, 1981
    Product Code
    KFZ
    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
    KFZ Humidifier, Non-Direct Patient Interface (Home-Use)

    Similar 510(k) Clearances

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

    THERASTEAM PERSONAL STEAM INHALER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    VIROTHERM HUMIDIFIER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    RHINOTHERM ULTRA 2

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    WH150 ROOM HUMIDIFIER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER

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