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

    RESPIR GARD-II FACE MASK CORRUGATED TUBING

    K Number: K853056 · Decision Aug 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    47
    Applicant Total
    32
    Review Days
    19

    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
    RESPIR GARD-II FACE MASK CORRUGATED TUBING
    K Number
    K853056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1390
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Marquest Medical Products, Inc.
    Date Received
    July 19, 1985
    Decision Date
    August 7, 1985
    Product Code
    IYT
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYT System, Rebreathing, Radionuclide

    Similar 510(k) Clearances

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

    Patient Administration Set

    FDA 510(k)
    FDA Class 2 ·Radiology

    XENON CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    XENON GAS BREATHING CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    XENON CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    TETLEY PATIENT ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·Radiology

    BOLUS XENON CIRCUIT

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

    Other Clearances by Marquest Medical Products, Inc.

    K Number Device Name
    K050066 C-CO2 COLORIMETRIC CO2 INDICATOR
    K970478 SCT 3000 HEATED HUMIDIFIER
    K962220 HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
    K962223 WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
    K960972 DISPOSABLE GAS SAMPLING INTERFACE KITS
    K961838 RESPIRGARD II, SPIROGARD
    K904690 TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM
    K903138 MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM
    K902632 GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
    K903307 TEMP MARQ TEMPERATURE TREND INDICATOR
    Search all 32 clearances from Marquest Medical Products, Inc. →