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

    RESPIRONICS PTL REVIVEEASY

    K Number: K863172 · Decision Nov 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    172
    Review Days
    78

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    Basic Information

    Device Name
    RESPIRONICS PTL REVIVEEASY
    K Number
    K863172
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5650
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Respironics, Inc.
    Date Received
    August 18, 1986
    Decision Date
    November 4, 1986
    Product Code
    CAO
    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
    CAO Airway, Esophageal (Obturator)

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