BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Technical Services for Electronics, Inc.

    Reg #: 3008483389 · FEI: 3008483389 · Expires 2025
    View on FDA
    Products
    33
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    33

    Registration Details

    Registration Name
    Technical Services for Electronics, Inc.
    Registration Number
    3008483389
    FEI Number
    3008483389
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2F, 5F No. 21 Jiankang Rd., Zhonghe District
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K131414

    Owner / Operator

    Firm Name
    Technical Services for Electronics, Inc.
    Operator Number
    10032893
    Address
    7800 Equitable Dr
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US
    Correspondent
    Rob MacNamara

    US Agent

    Business Name
    Ametek EMC
    Contact Name
    Rob MacNamara
    Address
    7800 Equitable Drive, Suite 250
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US
    Email
    [email protected]
    Phone
    612 2190466

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Full-Montage Standard Electroencephalograph GWQ
    Oximeter DQA
    Computer, Oxygen-Uptake BZL
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Computer, Diagnostic, Programmable DQK
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Burst Suppression Detection Software For Electroencephalograph ORT
    Monitor, Breathing Frequency BZQ
    Alarm, Blood-Pressure DSJ
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Stimulator, Nerve, Peripheral, Electric KOI
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Stimulator, Auditory, Evoked Response GWJ
    Electrocardiograph DPS
    Probe, Thermodilution KRB
    Computer, Blood-Pressure DSK
    Monitor, St Segment With Alarm MLD
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Oximeter, Ear DPZ
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Reduced- Montage Standard Electroencephalograph OMC
    Index-Generating Electroencephalograph Software OLW
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Continuous Measurement Thermometer FLL
    Detector And Alarm, Arrhythmia DSI

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)