Electromagnetic Compatibility

Electromagnetic Compatibility (EMC) is a testing program with a primary goal of identifying the sources of electromagnetic energy emitted from an electronic device in an effort to reduce potential interference to other equipment, as well as determining the susceptibility of the equipment from electromagnetic energy emitted by other electronic devices nearby.

SubCon Manufacturing Corporation has completed this testing on the model 1029 , demonstrating compliance with the requirements of Electromagnetic Compatibility (EMC), Parts 3-2, EN 61000-3-2 & E lectromagnetic Compatibility (EMC), Part 3. EN 61000-3-3.

Underwriters Laboratories Inc. (UL)  / Canadian Standards Association (CSA)

UL is a product safety testing organization and is certified as a Nationally Recognized Testing Laboratory (NRTL) with US, Canadian, and global product safety certifications.

SubCon Manufacturing Corporation has completed the safety testing on the Model 1029 , demonstrating compliance with the appropriate safety requirements. This compliance and testing to UL Standard 60601-1, Medical Electrical Equipment , Part 1; General Requirements and Canadian Standards Association (CSA), Medical Electrical Equipment, Part 1; General Requirements for Safety, Standard C22.2 No. 601.1-M90 allows the medical products manufactured by SubCon Manufacturing Corporation to display the familiar UL / CSA marking .

Food and Drug Administration (FDA)

The FDA is a Federal agency within the US that governs the public health by assuring the safety of products through evaluating the benefits and risks of their intended use and by auditing the manufacturer’s quality program for compliance.

SubCon Manufacturing Corporation is a Registered Company with the Food and Drug Administration with products in the medical device category. This was accomplished by compliance to the requirements of 21 CFR Part 820 Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule.

FDA

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