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

    MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH

    K Number: K870840 · Decision Jun 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    23
    Applicant Total
    39
    Review Days
    106

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    Basic Information

    Device Name
    MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH
    K Number
    K870840
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Directed Energy, Inc.
    Date Received
    February 26, 1987
    Decision Date
    June 12, 1987
    Product Code
    EWG
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EWG Laser, Ent Microsurgical Carbon-Dioxide

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    Other Clearances by Directed Energy, Inc.

    K Number Device Name
    K904930 SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH
    K894241 MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT
    K883738 CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.
    K882926 MODEL AU-1 ACCESSORY UNIT
    K880216 MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.
    K873331 ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG
    K870841 MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
    K872709 MODEL 20-C, RL-20A/U, OB-10A/U
    K872711 MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY
    K872710 MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT
    Search all 39 clearances from Directed Energy, Inc. →