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

    OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM

    K Number: K911770 · Decision Oct 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    21
    Review Days
    179

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    Basic Information

    Device Name
    OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM
    K Number
    K911770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Automatic Liquid Packaging, Inc.
    Date Received
    April 19, 1991
    Decision Date
    October 15, 1991
    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.

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    K980147 YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
    K973829 IRRIGATION BOTTLE
    K962079 HUMIDIFIER ADAPTER
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    K920306 OPTI-MOL FILTERED PUNCTURE PIN
    K901762 PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM
    K901362 ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
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