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

    SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE

    K Number: K953349 · Decision Feb 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    4
    Review Days
    227

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    Basic Information

    Device Name
    SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE
    K Number
    K953349
    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
    July 17, 1995
    Decision Date
    February 29, 1996
    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
    K982225 SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
    K973347 TSX PRM PULMONARY RESUSCITATION MONITOR
    K963755 SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR