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

    EMERSON CHEST RESPIRATOR, MODEL 33-CRE

    K Number: K881808 · Decision Aug 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    20
    Applicant Total
    25
    Review Days
    98

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    Basic Information

    Device Name
    EMERSON CHEST RESPIRATOR, MODEL 33-CRE
    K Number
    K881808
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5935
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    J. H. Emerson Co.
    Date Received
    April 28, 1988
    Decision Date
    August 4, 1988
    Product Code
    BYT
    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
    BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)

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    Other Clearances by J. H. Emerson Co.

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    K924174 EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA
    K902764 EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
    K896721 MODEL 7-AT TREATMENT CHAMBER
    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
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