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

    TRAY, BLOOD SAMPLING (PULSATOR II)

    K Number: K760086 · Decision Jul 16, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    42
    Review Days
    25

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    Basic Information

    Device Name
    TRAY, BLOOD SAMPLING (PULSATOR II)
    K Number
    K760086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Concord Laboratories, Inc.
    Date Received
    June 21, 1976
    Decision Date
    July 16, 1976
    Product Code
    GJE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GJE Tray, Blood Collection

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    Other Clearances by Concord Laboratories, Inc.

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    K854327 SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
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    K842095 EPIDURAL TRAYS
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