BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CPR BIO-BARRIER FACESHEILD

    K Number: K960995 · Decision Jan 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    14
    Review Days
    301

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    Basic Information

    Device Name
    CPR BIO-BARRIER FACESHEILD
    K Number
    K960995
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    O-Two Systems Intl., Inc.
    Date Received
    March 12, 1996
    Decision Date
    January 7, 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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