Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008483389

FEI Number

3008483389

Entity Name

Technical Services for Electronics, Inc.

City/State/Country

New Taipei City, TW

Establishment Address

1F, 2F, 5F No. 21 Jiankang Rd., Zhonghe District, New Taipei City 235, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Technical Services for Electronics, Inc. (Owner Number: 10032893)

Owner / Operator Contact Address

7800 Equitable Dr, Eden Prairie, MN 55344, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cable assembly, cardiac GE Healthcare Cable Assy, NIBP Hose, Adult 3.6M Sub-Min GE Health Care Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables) ECG Trunk Cables and Leadwires EnSite Cable Assembly, (Dual/Single) BP & Temperature Monitoring

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2014-09-24
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-06-24
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-06-23
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2010-06-23
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2013-03-05
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2013-03-05
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2013-03-05
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2013-03-05
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2013-03-05
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2013-03-05
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2014-01-06
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2018-07-31
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2012-04-26
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2019-01-03
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2019-01-03
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2019-01-03
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2019-01-03
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2019-01-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2019-01-03
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2019-01-03
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2019-01-03
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2019-01-03
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2019-01-03
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2019-01-03
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2019-01-03
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2019-01-03
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2019-01-03
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2019-01-03
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2019-01-03
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2019-01-03
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2019-01-03
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2019-01-03
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2019-01-03
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2019-01-03
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2019-01-03
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2019-01-03
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2019-01-03
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2019-01-03
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2019-01-03
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2019-01-03
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2019-01-03
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2019-01-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-01-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-01-03
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-01-03
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2019-01-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2014-11-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-06-08

Official Correspondent

Rob MacNamara

US Agent Details

Rob MacNamara Business: Ametek EMC Email: rob.macnamara@ametek.com Phone: (612) 2190466

Related Public Records

Same Entity

Technical Services for Electronics, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K993974	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	2000-02-22
K182075	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	2018-12-10
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K972535	Odam	MAGLIFE C	1998-01-13
K170567	Remote Diagnostic Technologies , Ltd.	Tempus Pro Patient Monitor	2017-07-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Z-1729-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008483389. Last updated year: 2026. Please use registration number 3008483389 when referencing this establishment in official correspondence.