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

    EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA

    K Number: K924174 · Decision Nov 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    24
    Applicant Total
    25
    Review Days
    90

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    Basic Information

    Device Name
    EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA
    K Number
    K924174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    J. H. Emerson Co.
    Date Received
    August 19, 1992
    Decision Date
    November 17, 1992
    Product Code
    NHJ
    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
    NHJ Device, Positive Pressure Breathing, Intermittent

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    Other Clearances by J. H. Emerson Co.

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    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
    K864379 EMERSON 3MV VOLUME VENTILATOR
    K864394 EMERSON 3MV VOLUME VENTILATOR
    Search all 25 clearances from J. H. Emerson Co. →