BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STarFix Designer Software

    Reg #: 3002250546 · FEI: 3002250546 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    FHC, INC.
    Registration Number
    3002250546
    FEI Number
    3002250546
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1201 MAIN ST
    City
    Bowdoin
    State
    ME
    ZIP
    04287
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231141

    Owner / Operator

    Firm Name
    FHC, Inc.
    Operator Number
    9037838
    Address
    1201 Main St., --
    City
    Bowdoin
    State
    ME
    Postal Code
    04287
    Country
    US

    Products

    Device Name Product Code
    Surgical Planning Software For Neurological Stereotaxic Instruments QRI
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    STarFix Designer Software

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198