Tuesday, December 3, 2024

Tuesday, December 3, 2024

NETECH CORPORATION: Netech Obtains FDA 510(k) Clearance for Delta 3300 - Defibrillator/Pacemaker Analyzer


Delta 3300  

Netech Corporation issued the following announcement on Sep. 9.

Leading biomedical test-instrument manufacturer Netech announced today the launch of its new state-of-the-art defibrillator/pacemaker analyzer—the Delta 3300. Recently approved by the FDA 510(k), the Delta 3300 is a precision instrument for testing and validating the functions of all semi and automated defibrillators. This revolutionary compact, easy-to-use analyzer measures both monophasic and biphasic waveforms, including external (transcutaneous) pacemakers. 

 For over 32 years, Netech has been a pioneer in designing innovative biomedical test instruments by consistently adapting to the changing needs of the industry. Netech prides itself as a leader in delivering high-quality products, at the best value that fit the requirements of today's marketplace.

"The Delta 3300 is the smallest and lightest defib analyzer in the market today;" said Wijin Joe, National Business Development Manager for Netech Corporation. "This cutting edge product combines the testing functions of a defibrillator, Transcutaneous Pacemaker Analyzer, and 12-Lead ECG / Arrhythmia Simulator." 

Some highlight test functions of the Delta 3300 include - Energy measurement, Peak Discharge voltage and current, Cardioversion measurement, Waveform storage and playback, simulation of 12 lead ECG and Arrhythmia waveforms. Additionally, the transcutaneous measurement features of the device include pacer pulse rate, width, amplitude, energy, demand sensitivity, refractory period, and immunity.

The Delta 3300 is exceptionally portable and rugged; it is designed with field service personnel in mind, as it allows for bench top and on-the-go applications. This device also provides functions for the testing and validation of various types of AEDs. The Delta 3300 features the ability to save and print test data, making it ideal for record-keeping using the software included.

Housed in a compact ABS plastic case, the Delta 3300 is the quintessential product for every biomedical maintenance personnel. This lightweight device features a large backlit LCD screen displaying clear and detailed results. A long-lasting, rechargeable Li-ion battery powers the Delta 3300.

The Delta 3300 is available at a special introductory price for a limited time. With a reputation for quality, reliability, and value, Netech's innovative products are designed using the newest technologies that demonstrate an unyielding commitment to the medical and other industries worldwide.

Netech is ISO 9001-2015 registered and SBA 8(a) certified company, along with US FDA registrations. The organization follows good manufacturing practices and complies with quality systems regulation 21CHR820. For more information on Netech products, visit www.NetechCorp.us

Original source can be found here.

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