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

    SPI-RISE

    K Number: K822359 · Decision Aug 27, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    107
    Applicant Total
    2
    Review Days
    21

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    Basic Information

    Device Name
    SPI-RISE
    K Number
    K822359
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Certified Respiratory Services, Inc.
    Date Received
    August 6, 1982
    Decision Date
    August 27, 1982
    Product Code
    BWF
    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
    BWF Spirometer, Therapeutic (Incentive)

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    Other Clearances by Certified Respiratory Services, Inc.

    K Number Device Name
    K822685 NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY