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

    NTI TENSION SUPPRESSION SYSTEM

    K Number: K010876 · Decision Jun 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    89

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    Basic Information

    Device Name
    NTI TENSION SUPPRESSION SYSTEM
    K Number
    K010876
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nti-Tss, Inc.
    Date Received
    March 23, 2001
    Decision Date
    June 20, 2001
    Product Code
    OCO
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OCO Mouthguard, Migraine/Tension Headache

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    Other Clearances by Nti-Tss, Inc.

    K Number Device Name
    K041184 NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION