BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PROLAIO INC.

    Reg #: 3030597723 · FEI: 3030597723 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    PROLAIO INC.
    Registration Number
    3030597723
    FEI Number
    3030597723
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    230 W Monroe St Ste 2560
    City
    Chicago
    State
    IL
    ZIP
    60606
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142512

    Owner / Operator

    Firm Name
    Prolaio Inc.
    Operator Number
    10090226
    Address
    230 W Monroe, Suite 2560
    City
    Chicago
    State
    IL
    Postal Code
    60606
    Country
    US
    Correspondent
    George A Hides

    Products

    Device Name Product Code
    Multivariate Vital Signs Index PLB
    Electrocardiograph DPS
    Medical Device Data System OUG
    Adjunctive Cardiovascular Status Indicator PPW

    Proprietary Names

    prolaio Personalized Physiology Analytics Engine Software prolaio Heart Rhythm and Respiration Module prolaio Heart Rhythm Module prolaio Medical Device Data System Platform prolaio eVO2peak Module (1)

    Establishment Types

    Manufacture Medical Device