CONTEC™ Electrocardiograph
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Electrocardiograph EUDAMEDCONTEC FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- Electrocardiograph EUDAMEDFDA UDI
- Model / Reference
- ECG1200G EUDAMEDFDA UDIECG90A EUDAMEDFDA UDIECG1212G, ECG90A, ECG300G, ECG600G, ECG1200G, E3, E3M, E6, E12, E18M EUDAMEDECG600G EUDAMEDE3M EUDAMEDE18M EUDAMEDE6 EUDAMED
- Description
- Electrocardiograph FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945040100492 EUDAMEDFDA UDI06945040103462 EUDAMEDFDA UDI06945040100485 EUDAMED06945040108801 EUDAMED06945040107309 EUDAMED06945040108818 EUDAMED
- Basic UDI-DI
- 69450401ECG1212G5V EUDAMED
- Direct Marketing DI
- 06945040103462 EUDAMED06945040100485 EUDAMED06945040108801 EUDAMED06945040100492 EUDAMED06945040107309 EUDAMED06945040108818 EUDAMED
- FDA Product Code
- DPS FDA 510(k)FDA UDI
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.2340 FDA 510(k)
- Regulation Number
- 870.2340 FDA 510(k)FDA UDI
- Market of Registration
- France EUDAMEDPoland EUDAMEDGreece EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The ECG300G Electrocardiograph is a 12-lead electrocardiograph designed to simultaneously acquire and record ECG signals. It functions as a diagnostic tool for evaluating cardiac electrical activity, providing waveform analysis, automatic parameter measurement, and real-time display of heart rhythms in both automatic and manual modes.
This device is intended for use in clinical settings, featuring a thermal printing system for waveform output and multi-language interface support. It operates on both AC and DC power and includes lead-off and paper-jam alerts. Supplied as a reusable medical device, it complies with FDA 510(k) clearance under the Cardiovascular advisory committee and EU MDR regulations. No single-use or MRI safety information is specified.
Frequently asked questions
What clinical applications does the CONTEC™ Electrocardiograph support in evaluating heart function?
The CONTEC™ Electrocardiograph is designed to evaluate cardiac electrical activity through 12-lead ECG acquisition, providing real-time waveform analysis and automatic parameter measurements. It supports both automatic and manual modes for assessing heart rhythms, making it useful for diagnosing arrhythmias, myocardial ischemia, and other cardiac conditions in clinical settings.
Is the CONTEC™ Electrocardiograph intended for single-use or reusable in a healthcare facility?
The device is explicitly supplied as a reusable medical device, meaning it is intended for repeated use in clinical environments after proper cleaning and maintenance. There is no indication of single-use or MRI compatibility in the specifications.
What types of alerts does the CONTEC™ Electrocardiograph include to improve usability?
The device features lead-off alerts to notify users if electrodes are improperly attached, as well as paper-jam alerts to signal issues with the thermal printing system. These alerts help ensure accurate waveform recording and uninterrupted operation.
What power sources can the CONTEC™ Electrocardiograph operate on, and does it support multiple languages?
The ECG300G operates on both AC and DC power, providing flexibility for use in various clinical settings. Additionally, it includes a multi-language interface to accommodate healthcare providers from different regions.
How is the regulatory pathway for the CONTEC™ Electrocardiograph defined, and which committees were involved?
The device follows a traditional 510(k) clearance pathway under the FDA, classified as substantially equivalent (SESE) and reviewed by the Cardiovascular (CV) advisory committee. It also complies with EU MDR regulations, indicating its approval status in both markets.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ECG300G Electrocardiograph-CONTEC MEDICAL SYSTEMS CO.,LTD, ECG300GA Electrocardiograph-CONTEC MEDICAL SYSTEMS CO.,LTD, CONTEC ECG300G Electrocardiograph,Digital 3 Channel 12 lead EKG
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171360 | Class II | Active |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- FDA Applicant
- Contec Medical Systems Co.,Ltd
Sources (9)
- FDA 510(k) K171360 24 fields · synced Sep 18, 2026
- FDA UDI 3bc45ab7-698f-48be-8687-6a8dfc29d539 34 fields · synced May 29, 2026
- FDA UDI 9c6ba53b-b6a2-4295-95af-522b5e19980d 34 fields · synced May 30, 2026
- EUDAMED d1205ea5-c819-41bd-ac40-66620e0e9486 61 fields · synced Jun 20, 2026
- EUDAMED 63811ccd-2d70-4379-bcd3-be1adebc9746 61 fields · synced Jul 9, 2026
- EUDAMED 3f61a3b0-3b73-4534-933d-ddd38950bafc 61 fields · synced Jul 16, 2026
- EUDAMED a1a2fd98-199d-490d-8c8c-29b7c7e89e36 61 fields · synced Jul 18, 2026
- EUDAMED 82e3f34e-97b6-48e0-838f-f1521bdfe047 61 fields · synced Jul 30, 2026
- EUDAMED c0417a9c-5fbe-476a-8f05-07bbadb3fe33 61 fields · synced Sep 17, 2026