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

    SEA MEDICAL PRODUCTS LO-VOL

    K Number: K811847 · Decision Jul 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    12

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    Basic Information

    Device Name
    SEA MEDICAL PRODUCTS LO-VOL
    K Number
    K811847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Sea Medical Products, Inc.
    Date Received
    July 1, 1981
    Decision Date
    July 13, 1981
    Product Code
    FPK
    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
    FPK Tubing, Fluid Delivery

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    Other Clearances by Sea Medical Products, Inc.

    K Number Device Name
    K811561 LO-VOL I.V. SETS