BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SENTEC, INC.

    Reg #: 3012409105 · FEI: 3012409105 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    SENTEC, INC.
    Registration Number
    3012409105
    FEI Number
    3012409105
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    40 Albion Road, Suite 100
    City
    Lincoln
    State
    RI
    ZIP
    02865
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151329

    Owner / Operator

    Firm Name
    Sentec, Inc.
    Operator Number
    10051986
    Address
    40 Albion Road, Suite 100
    City
    Lincoln
    State
    RI
    Postal Code
    02865
    Country
    US
    Correspondent
    Stephen H Gorski

    Products

    Device Name Product Code
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia LPP
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Oximeter, Ear DPZ

    Proprietary Names

    Ear Clip Sentec Digital Monitoring System V-Sign Sensor 2 OxiVenT Sensor Sentec Digital Monitor Staysite Adhesive pad V-STATS PC software Multi-Site Attachment Rings

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198