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

    SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE

    K Number: K954438 · Decision Dec 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    63
    Applicant Total
    10
    Review Days
    95

    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
    SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE
    K Number
    K954438
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5540
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rms Div.
    Date Received
    September 25, 1995
    Decision Date
    December 29, 1995
    Product Code
    CCW
    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
    CCW Laryngoscope, Rigid

    Similar 510(k) Clearances

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

    APA Oxy Blade

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    YEESCOPE LARYNGOSCOPES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    AIRTRAQ SP AIRTRAQ AVANT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    TRU-MR LARYNGOSCOPE SET

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

    Other Clearances by Rms Div.

    K Number Device Name
    K963367 RMS K-WIRE
    K944848 THE VIVACARE T.P.S. PROBE
    K944557 DW250 #91
    K941625 DW234 #29
    K902403 ELITE R/F SPOT FILM DRIVE
    K902146 SFD-035 SPOT FILM DEVICE
    K896665 EXT-600 TABLE, RADIOGRAPHIC, ELEVATING
    K896119 RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE
    K896324 ELITE 1500 RADIOGRAPHIC TILTING TABLE