BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SB-170P

    Reg #: 2080783 · FEI: 2080783 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    44
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    NIHON KOHDEN AMERICA, INC.
    Registration Number
    2080783
    FEI Number
    2080783
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    15353 Barranca Pkwy
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171765

    Owner / Operator

    Firm Name
    NIHON KOHDEN CORP.
    Operator Number
    8030227
    Address
    1-31-4 NISHIOCHIAI, SHINJUKU-KU
    City
    TOKYO
    State
    JP-13
    Postal Code
    161-8560
    Country
    JP

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Endoscopic Bite Block MNK

    Proprietary Names

    SB-170P YG-232T YG-214T DH-380P YG-122T JL-030U2 YG-213T TG-980P YG-282T TL-201T DH-171P TG-970P JL-030U1 TG-900P TL-062S TL-220T TL-051S TL-631T1 TG-920P YG-242T JL-500P1 TL-272T TL-535U TL-631T3 YS-100P7 YG-101T TL-273T TL-274T TL-273T3 YG-211T HIT-100 TL-052S DH-172P JG-900P TL-272T3 TL-061S TL-271T TL-271T3 TG-101T YG-227T KC-170P TL-274T3 YG-272T YG-111T

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device