BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    BODYGAURD PAIN MANAGER INFUSION SYSTEM

    K Number: K061325 · Decision Aug 24, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    9
    Review Days
    105

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    Basic Information

    Device Name
    BODYGAURD PAIN MANAGER INFUSION SYSTEM
    K Number
    K061325
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Caesarea Medical Electronics , Ltd.
    Date Received
    May 11, 2006
    Decision Date
    August 24, 2006
    Product Code
    FRN
    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
    FRN Pump, Infusion

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    Other Clearances by Caesarea Medical Electronics , Ltd.

    K Number Device Name
    K080954 T34L SYRINGE DRIVER
    K070235 BODYGUARD PAIN MANAGER INFUSION SYSTEM
    K070718 MODIFICATION TO: BODYGUARD INFUSION SYSTEM
    K060479 MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM
    K050800 NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
    K042696 BODYGUARD INFUSION PUMP SYSTEM
    K040957 NOA III ENTERAL NUTRITION PUMP
    K031749 BODYGUARD INFUSION SYSTEM