BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ETIOMETRY INC.

    Reg #: 3011683100 · FEI: 3011683100 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    ETIOMETRY INC.
    Registration Number
    3011683100
    FEI Number
    3011683100
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    770 Legacy Place, Floor 2, Suite 34
    City
    Dedham
    State
    MA
    ZIP
    02026
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241479

    Owner / Operator

    Firm Name
    Etiometry Inc.
    Operator Number
    10049448
    Address
    770 Legacy Place, Floor 2, Suite 34
    City
    Dedham
    State
    MA
    Postal Code
    02026
    Country
    US
    Correspondent
    Timothy Hanson

    Products

    Device Name Product Code
    Adjunctive Cardiovascular Status Indicator PPW
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Multivariate Vital Signs Index PLB
    Medical Device Data System OUG

    Proprietary Names

    Etiometry Platform Etiometry Platform Software T3 Platform software The Etiometry Platform EtioLink

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198