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

    ANAGO ISOLATION MASK (#80-950)

    K Number: K864116 · Decision Nov 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    44
    Review Days
    35

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    Basic Information

    Device Name
    ANAGO ISOLATION MASK (#80-950)
    K Number
    K864116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5450
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Anago, Inc.
    Date Received
    October 21, 1986
    Decision Date
    November 25, 1986
    Product Code
    LGM
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LGM Chamber, Patient Isolation

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    Other Clearances by Anago, Inc.

    K Number Device Name
    K925659 U.C.E.Z. LENS CLEANER KIT
    K930161 ANAGO SPINAL ANESTHESIA TRAY
    K926589 ANAGO WARM PACK
    K926590 ANAGO DISPOSABLE INSTANT COLD PACK
    K926137 ANAGO FEM-COOL/FEM-COOL PETITE
    K920615 ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT
    K915415 GUARDALL SHIELD
    K913558 RELIABLE CONE STYLE FACE MASK
    K905865 ANTI-FOR SURGICAL FACE MASK
    K905749 SURGICAL FACE MASK
    Search all 44 clearances from Anago, Inc. →