BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pylo Health 802-LTE Blood Pressure Monitor

    Reg #: 3017500903 · FEI: 3017500903 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PREVOUNCE HEALTH, INC
    Registration Number
    3017500903
    FEI Number
    3017500903
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3250 N Post Road, STE 180
    City
    Indianapolis
    State
    IN
    ZIP
    46226
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202891

    Owner / Operator

    Firm Name
    Prevounce Health, Inc
    Operator Number
    10078004
    Address
    3250, STE 180
    City
    Indianapolis
    State
    IN
    Postal Code
    46226
    Country
    US
    Correspondent
    Daniel Tashnek

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Pylo Health 802-LTE Blood Pressure Monitor Pylo Health 900-LTE Blood Pressure Monitor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198