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

    PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE

    K Number: K901920 · Decision Aug 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    1
    Review Days
    109

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    Basic Information

    Device Name
    PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
    K Number
    K901920
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Primecare, Inc.
    Date Received
    April 30, 1990
    Decision Date
    August 17, 1990
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

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