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

    INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330

    K Number: K092129 · Decision May 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    18
    Review Days
    307

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    Basic Information

    Device Name
    INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330
    K Number
    K092129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intersurgical, Inc.
    Date Received
    July 15, 2009
    Decision Date
    May 18, 2010
    Product Code
    BZE
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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    Other Clearances by Intersurgical, Inc.

    K Number Device Name
    K122077 MANOMETER
    K122075 DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER
    K121026 FLO-GUARD BREATHING FILTER
    K092451 INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
    K092409 HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
    K032322 CLEAR-THERM MICRO HME, MODEL 1441
    K024270 CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3
    K990949 CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT
    K983610 CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18
    K984481 EXHALATION VALVE
    Search all 18 clearances from Intersurgical, Inc. →