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

    SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR

    K Number: K963755 · Decision Apr 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    4
    Review Days
    202

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    Basic Information

    Device Name
    SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
    K Number
    K963755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Spiracle Technology
    Date Received
    September 18, 1996
    Decision Date
    April 8, 1997
    Product Code
    CBP
    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
    CBP Valve, Non-Rebreathing

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    Other Clearances by Spiracle Technology

    K Number Device Name
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    K973347 TSX PRM PULMONARY RESUSCITATION MONITOR
    K953349 SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE