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

    PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS

    K Number: K921178 · Decision Aug 26, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    7
    Applicant Total
    6
    Review Days
    170

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    Basic Information

    Device Name
    PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS
    K Number
    K921178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2550
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Associated Services, Inc.
    Date Received
    March 9, 1992
    Decision Date
    August 26, 1992
    Product Code
    JAX
    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
    JAX Pneumotachometer

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