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

    PERSONAL INFUSOR

    K Number: K971362 · Decision Dec 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    87
    Applicant Total
    4
    Review Days
    237

    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
    PERSONAL INFUSOR
    K Number
    K971362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Science Incorporated
    Date Received
    April 11, 1997
    Decision Date
    December 4, 1997
    Product Code
    MEB
    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
    MEB Pump, Infusion, Elastomeric

    Similar 510(k) Clearances

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

    SMARTeZ™ Elastomeric Infusion Pump (RS series)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    InfuLife

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ON-Q* Pump with Bolus

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SMARTez elastomeric infusion pump

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Science Incorporated

    K Number Device Name
    K020881 MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
    K010824 PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
    K990208 PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT