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

    EMERSON 3MV VOLUME VENTILATOR

    K Number: K864379 · Decision Dec 15, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    25
    Review Days
    40

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    Basic Information

    Device Name
    EMERSON 3MV VOLUME VENTILATOR
    K Number
    K864379
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    J. H. Emerson Co.
    Date Received
    November 5, 1986
    Decision Date
    December 15, 1986
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by J. H. Emerson Co.

    K Number Device Name
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    K920910 OXYGEN POWERED RESUSCITATOR FOR CPR
    K924174 EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA
    K902764 EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
    K896721 MODEL 7-AT TREATMENT CHAMBER
    K881808 EMERSON CHEST RESPIRATOR, MODEL 33-CRE
    K873489 EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000
    K872937 97-TD EMERSON TIMER/DIMMER CONTROL
    K872936 97-D EMERSON DIMMER CONTROL
    K864394 EMERSON 3MV VOLUME VENTILATOR
    Search all 25 clearances from J. H. Emerson Co. →