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

    THE BREATHE EASE NURSERY VAPOR TENT

    K Number: K884922 · Decision Feb 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    67

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    Basic Information

    Device Name
    THE BREATHE EASE NURSERY VAPOR TENT
    K Number
    K884922
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5710
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Cal-Trends Products
    Date Received
    November 28, 1988
    Decision Date
    February 3, 1989
    Product Code
    FNC
    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
    FNC Tent, Pediatric Aerosol