BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    PIvot Breath Sensor

    Reg #: 3033509895 · FEI: 3033509895 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SEACOMP DISPLAYS
    Registration Number
    3033509895
    FEI Number
    3033509895
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Andador Vecinal 15801, Fraccionamiento el Rosario
    City
    Tijuana Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K201206

    Owner / Operator

    Firm Name
    Seacomp Displays
    Operator Number
    10091907
    Address
    Andador Vecinal 15801, Fraccionamiento el Rosario
    City
    Tijuana
    State
    Baja California
    Postal Code
    22675
    Country
    MX
    Correspondent
    Ramiro Ornelas Chan

    US Agent

    Business Name
    Seacomp
    Contact Name
    Erik Sierks
    Address
    1525 Faraday Ave
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US
    Email
    [email protected]
    Phone
    224 7158811

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase CCJ

    Proprietary Names

    PIvot Breath Sensor

    Establishment Types

    Manufacture Medical Device