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

    PRESSURE MONITORING IV BOTTLE CAP

    K Number: K831867 · Decision Aug 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    10
    Review Days
    63

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    Basic Information

    Device Name
    PRESSURE MONITORING IV BOTTLE CAP
    K Number
    K831867
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Alto Development Corp.
    Date Received
    June 10, 1983
    Decision Date
    August 12, 1983
    Product Code
    DRS
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRS Transducer, Blood-Pressure, Extravascular

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    K931537 A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT
    K930528 A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS
    K914193 A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT
    K915300 A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES
    K884783 RANEY CLIP
    K881413 ELECTRO-CAUTERY SUCTION TUBE
    K821518 MYO/CLIP