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

    BIOSURGE MODEL OASYS

    K Number: K871258 · Decision May 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    5
    Review Days
    51

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    Basic Information

    Device Name
    BIOSURGE MODEL OASYS
    K Number
    K871258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Biosurge, Inc.
    Date Received
    March 31, 1987
    Decision Date
    May 21, 1987
    Product Code
    CAC
    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
    CAC Apparatus, Autotransfusion

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    Other Clearances by Biosurge, Inc.

    K Number Device Name
    K884620 ASD SINGLE LUMEN NEEDLE
    K875016 BIOSURGE MODEL ILVC-1
    K874602 ASD-BIO ANTI-STICK DEVICE
    K875023 BIOSURGE MODEL OASYS-II