BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Compumedics Siesta System

    Reg #: 1650946 · FEI: 3002716534 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    COMPUMEDICS USA, INC.
    Registration Number
    1650946
    FEI Number
    3002716534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5015 West WT Harris Blvd, Suite E
    City
    Charlotte
    State
    NC
    ZIP
    28269
    Country
    US

    Regulatory Submissions

    510(k) Number
    K003175

    Owner / Operator

    Firm Name
    Compumedics USA Inc.
    Operator Number
    9029712
    Address
    5015 W W.T. Harris Blvd, Suite E
    City
    Charlotte
    State
    NC
    Postal Code
    28269
    Country
    US
    Correspondent
    Bailey K Lewis

    Products

    Device Name Product Code
    Standard Polysomnograph With Electroencephalograph OLV
    Full-Montage Standard Electroencephalograph GWQ

    Proprietary Names

    Compumedics Siesta System

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198