BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GLOTTAL ENT., INC.

    Reg #: 1319182 · FEI: 1319182 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    GLOTTAL ENT., INC.
    Registration Number
    1319182
    FEI Number
    1319182
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1201 E. FAYETTE ST.
    City
    SYRACUSE
    State
    NY
    ZIP
    13210
    Country
    US

    Regulatory Submissions

    510(k) Number
    K901609

    Owner / Operator

    Firm Name
    GLOTTAL ENTERPRISES, INC.
    Operator Number
    1319182
    Address
    1201 E. FAYETTE ST., SUITE #15
    City
    Syracuse
    State
    NY
    Postal Code
    13210
    Country
    US
    Correspondent
    MARTIN - ROTHENBERG

    Products

    Device Name Product Code
    Transducer, Miniature Pressure IKE
    Electroglottograph KLX

    Proprietary Names

    PG-60 PG-20 EG2

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198