BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COMPUTER, CORE I5 3.2GHZ, 4GB (4307)

    Reg #: 2518897 · FEI: 1000080301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    60
    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

    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
    Electroglottograph KLX

    Proprietary Names

    COMPUTER, CORE I5 3.2GHZ, 4GB (4307) VOICE RANGE PROFILE - VRP PROGRAM (4326) FOOT SWITCH ASSEMBLY EPK (7193-5500) 5 AIRFLOW HEAD-MASK COUPLERS (6613) HAND-HELD SEPARATOR KIT (6453) PHONATORY AERODYNAMICS SYS FOR CSL USERS (6600-1) MICROPHONE PRE-AMP (3708) NASOMETER II - JAPAN (6450-JP) MICROPHONE ACCESSORY KIT (4345) SONA-SPEECH II (3650) PRESS. PORT TUBES 25QTY (6614) CONDENSER MICROPHONE (4302) MICROPHONE, DYNAMIC (3709) PEDIATRIC MASK W/ADAPTOR (6606) REAL TIME SPECTROGRAM (5129) SWITCH BOX ASSEMBLY A-B (7190-2500) NASOMETER II (6450) ADSV (5109) COMPUTERIZED SPEECH LAB (4500) ADULT FACE MASK, EXTRA (6602) HEADSET CUSHIONS (6455) V4 VISI-PITCH WIN10 UPGRADE (3950WU) SONA MATCH (5127) 30 ADULT LARGE DISPOSABLE MASK (6645) FLOWHEAD, EXTRA (6601) MICROPHONE FOR MULTISPEECH (3706) SPEECH MASTER UPGRADE (5298) FLOWHEAD TUBES, SET OF 8 (7189-4200) MOTOR SPEECH PROFILE (5141) MULTI SPEECH (3700) COMPUTERIZED SPEECH LAB - JAPAN (4500-JP) CARDBOARD TUBES 2 CASES OF 55 (6610) REAL-TIME PITCH (5121) VISI-PITCH (3950c) GAMES, SOFTWARE (5167B) 30 ADULT MED. DISPOSABLE MASKS (6635) SCREENING TUBES, QTY 10 (6612) INTRAORAL TUBES, QTY 50 (6611) 30 ADULT SMALL DISPOSABLE MASK (6625) V4 CSL WIN10 UPGRADE (4500WU) PHONATORY AERODYNAMIC SYSTEM (6600) VOICE ANALYSIS PROGRAM (9223) CARRYING CASE FOR NASOMETER - 1111-1791 (6454) 30 PEDIATRIC DISPOSABLE MASKS (6615) LAPTOP COMPUTER (4307-1) MULTI DIMENSIONAL VOICE PROG (5105) VISI-PITCH IV (3950B) V4 PAS WIN10 UPGRADE (6600WU) VISI-PITCH IV - JAPAN (3950B-JP) I-CAPE V SOFTWARE MODULE (5168) STEINBERG PRE-AMP KIT (3714) AUDITORY FEEDBACK MODULE (3506) COMPUTERIZED SPEECH LAB (4500b) NASOMETER HEADSET (6501) V4 NASOMETER WIN10 UPGRADE (6450WU) TUBES, MOUTHPIECE, QTY 55 (7189-4000) Nasometer II (6500) PAS DISPOSABLE ACCESSORIES KIT (6650) MIC and PREAMP for Multispeech(3706-1) Mic Preamp Kit(3715)

    Establishment Types

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