BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    WHITE BALANCE ADJUSTER (OS-A43H)

    Reg #: 9610877 · FEI: 3008185830 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    2

    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
    K172156

    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
    Nasopharyngoscope (Flexible Or Rigid) EOB

    Proprietary Names

    WHITE BALANCE ADJUSTER (OS-A43H) ETO STERILIZATION VENTING CAP (OF-C5) CARRYING CASE FOR VNL-J10 SERIES (VE-B22) VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL11-J10) O RING SET (OF-B214) LAMP FOR EPK-3000 (OL-X30) SINGLE USE SUCTION CONTROL VALVE (OF-B205) VIDEO PROCESSOR (EPK-3000) CLEANING ADAPTER (OF-B212) VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL15-J10) CLEANING ADAPTER FOR INLET (OF-B218) CONDENSER EARTH CABLE (OL-Z4) VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL8-J10) SOAKING CAP (OE-C9) RUBBER INLET SEAL SINGLE PIECE , STD (OF-B190) EPK-PROMO(EPK-3000 Campaign Discount) KEYBOARD FOR EPK-3000 (OS-A94)

    Establishment Types

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