BEUDAMED
    FDA Registration Active 🇺🇸 United States

    XENON BULB (2140-0028)

    Reg #: 2518897 · FEI: 1000080301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    PENTAX of America, Inc.
    Registration Number
    2518897
    FEI Number
    1000080301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3 Paragon Drive
    City
    MONTVALE
    State
    NJ
    ZIP
    07645
    Country
    US

    Regulatory Submissions

    510(k) Number
    K921184

    Owner / Operator

    Firm Name
    HOYA Corporation PENTAX Division
    Operator Number
    8030235
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    Postal Code
    07645
    Country
    US
    Correspondent
    Gurvinder Nanda

    Products

    Device Name Product Code
    Laryngostroboscope EQL

    Proprietary Names

    XENON BULB (2140-0028) MIC, LAPEL ASSY REV D (7175-6000) ENDOSCOPE ADAPTER (9124) WOLFE ADAPTER FOR PENTAX SCOPE (9122D) ADAPTOR FOR STORZ (9121) LARYNGEAL STROBE (9400) PENTAX ADAPTOR W/O FILTER (9122B) ENDOSCOPE ADAPTER (9125) WOLF RIGID SCOPE ADAPTOR (9123) PENTAX ADAPTOR (9122) ADAPTOR FOR OLYMPUS (9120) PENTAX ADAPTOR W/ FILTER (9122C) 150W HALOGEN LAMP (MU0P00000705) LARYNGEAL MICROPHONE (MU0P00000718) FOOT SWITCH MODULE (7192-9300)

    Establishment Types

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