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

    PALL ULTIPOR ANESTHESIA BREATHING SYSTEM

    K Number: K013093 · Decision Aug 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    6
    Review Days
    318

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    Basic Information

    Device Name
    PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
    K Number
    K013093
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pall Medical
    Date Received
    September 17, 2001
    Decision Date
    August 1, 2002
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    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
    CAH Filter, Bacterial, Breathing-Circuit

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    Other Clearances by Pall Medical

    K Number Device Name
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    K030469 LAPAROSHIELD CONDITIONED INSUFFLATION SET
    K992361 PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
    K983735 PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE
    K983731 PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE