BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SANISERV SURGICAL SLUSH SYSTEM

    K Number: K894006 · Decision Nov 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    151

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SANISERV SURGICAL SLUSH SYSTEM
    K Number
    K894006
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Saniserv, Inc.
    Date Received
    June 5, 1989
    Decision Date
    November 3, 1989
    Product Code
    JRM
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JRM Freezer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JRM), ordered by most recent decision date.

    ORS-100

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ORS-300

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ORS-200

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ORS-1000

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SELF-CONTAINED SURGICAL SLUSH FREEZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LANCER ICE CUBE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all