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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    HI-FLO THERME PNEU 45, WISAP #7083, 7083V

    K Number: K031014 · Decision Jun 27, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    9
    Review Days
    88

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    Basic Information

    Device Name
    HI-FLO THERME PNEU 45, WISAP #7083, 7083V
    K Number
    K031014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
    Date Received
    March 31, 2003
    Decision Date
    June 27, 2003
    Product Code
    HIF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIF Insufflator, Laparoscopic

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    Other Clearances by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

    K Number Device Name
    K011510 MULTI HI-FLO PNEU, WISAP #7080
    K992481 CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
    K992513 THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
    K990662 DISPOSABLE HEATING TUBING SET #7642HSES
    K982515 POWER-DRIVE, WISAP MODEL #7688PD/7688PD1
    K982518 AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
    K960640 S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
    K952508 FLOW-THERME, WISAP #7642