BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Saans (F4-01-00-000-000)

    K Number: K251165 · Decision Jan 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    266

    Basic Information

    Device Name
    Saans (F4-01-00-000-000)
    K Number
    K251165
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innaccel Technologies Private Limited
    Date Received
    April 15, 2025
    Decision Date
    January 6, 2026
    Product Code
    SGR
    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
    SGR Noninvasive Positive Airway Pressure System, Facility Use

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