BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    VIDEO PROCESSOR (EPK-i5500C)

    Reg #: 9610877 · FEI: 3008185830 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    HOYA Corporation PENTAX Lifecare Division
    Registration Number
    9610877
    FEI Number
    3008185830
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Tsutsujigaoka 1-1-110
    City
    Akishima-shi Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K190805

    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

    US Agent

    Business Name
    HOYA CORPORATION PENTAX DIVISION
    Contact Name
    Gurvinder Nanda
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    ZIP
    07645
    Country
    US
    Email
    [email protected]
    Phone
    201 5712318

    Products

    Device Name Product Code
    Endoscope, Accessories, Image Post-Processing For Color Enhancement PEA
    Colonoscope And Accessories, Flexible/Rigid FDF
    Gastroscope And Accessories, Flexible/Rigid FDS

    Proprietary Names

    VIDEO PROCESSOR (EPK-i5500C) IMAGINA COLONOSCOPE (EC34-i10CL) IMAGINA COLONOSCOPE (EC38-i10CL) IMAGINA VENTING CONNECTOR ADAPTER (OE-C29) VIDEO GASTROSCOPE (EG29-i10C) PENTAX Medical Ventilation Cap(OE-C28) PENTAX Medical keyboard EN (OS-A116) PENTAX Medical keyboard EN (OS-A111)

    Establishment Types

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