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

    PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM

    K Number: K901762 · Decision Jul 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    21
    Review Days
    90

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    Basic Information

    Device Name
    PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM
    K Number
    K901762
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Automatic Liquid Packaging, Inc.
    Date Received
    April 18, 1990
    Decision Date
    July 17, 1990
    Product Code
    BTT
    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
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Automatic Liquid Packaging, Inc.

    K Number Device Name
    K994321 STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
    K000964 STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
    K980147 YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
    K973829 IRRIGATION BOTTLE
    K962079 HUMIDIFIER ADAPTER
    K955104 HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
    K920306 OPTI-MOL FILTERED PUNCTURE PIN
    K911770 OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM
    K901362 ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
    K901301 STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
    Search all 21 clearances from Automatic Liquid Packaging, Inc. →