BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HUMID-VENT 2 S

    K Number: K881644 · Decision Jun 10, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    72
    Applicant Total
    6
    Review Days
    56

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    Basic Information

    Device Name
    HUMID-VENT 2 S
    K Number
    K881644
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Gibeck Respiration
    Date Received
    April 15, 1988
    Decision Date
    June 10, 1988
    Product Code
    BYD
    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
    BYD Condenser, Heat And Moisture (Artificial Nose)

    Similar 510(k) Clearances

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    TYPE 1 & 2 (HUMIDAIR I & II)

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    HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT

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    HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE

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    Other Clearances by Gibeck Respiration

    K Number Device Name
    K881657 HUMID-VENT FILTER
    K881656 HUMID-VENT 2 S FLEX
    K873768 HUMID-VENT(R) 2 PORT
    K873767 HUMID-VENT(R) MINI
    K872153 STOM-VENT