BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PREVOUNCE HEALTH, INC

    Reg #: 3017500903 · FEI: 3017500903 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    PREVOUNCE HEALTH, INC
    Registration Number
    3017500903
    FEI Number
    3017500903
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3250 N Post Road, STE 180
    City
    Indianapolis
    State
    IN
    ZIP
    46226
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140582

    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
    Oximeter DQA
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Scale, Stand-On, Patient FRI
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    OX1-LTE Pulse Oximeter Pylo Health Lancing Device GL1-LCT Pylo Health PY-802-LTE Blood Pressure Monitor Pylo Health 802-LTE Blood Pressure Monitor Pylo Health 900-LTE Blood Pressure Monitor Pylo Health Control Solution GL1-CTR Pylo Health 300-LTE Weight Scale Pylo Health 200-LTE Weight Scale Pylo Blood Glucose Meter Device GL1-LTE Pylo Health 1775-N Blood Pressure Monitor

    Establishment Types

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