BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    TONOMETER – MODEL A900

    Reg #: 3015972897 · FEI: 3015972897 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INNOVA MEDICAL OPHTHALMICS
    Registration Number
    3015972897
    FEI Number
    3015972897
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    136 Sparks Avenue
    City
    Toronto Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K022054

    Owner / Operator

    Firm Name
    Innova Medical Ophthalmics
    Operator Number
    10062378
    Address
    136 Sparks Avenue
    City
    Toronto
    State
    Ontario
    Postal Code
    M2H 2S4
    Country
    CA
    Correspondent
    Mary Anne Bembridge

    US Agent

    Business Name
    Sunbreak Investments, LLC dba Vision28
    Contact Name
    Rich Wynkoop
    Address
    915 Sw Rimrock Way Ste 201-402
    City
    Redmond
    State
    OR
    ZIP
    97756
    Country
    US
    Email
    [email protected]
    Phone
    541 6049654

    Products

    Device Name Product Code
    Tonometer, Manual HKY

    Proprietary Names

    TONOMETER – MODEL A900 TONOMETER – MODEL F900

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device