FDA Grants Clearance for Biomedical Electrical Safety Analyzer
The United States Food and Drug Administration (FDA) announced today it has granted Fluke Biomedical clearance for the new automated, multifunctional ESA615 Electrical Safety Analyzer 510(k). Now, medical device quality and safety professionals can test to the newest safety standards in just minutes, using this all-in-one automated test tool.
The ESA615 offers built-in standardized test sequences so every test is executed quickly and accurately with clear pass/fail indication of test results. It tests to the new IEC62353 (VDE751), IEC60601-1 (2nd and 3rd editions), ANSI/AAMI ES-1, NFPA-99, and AS/NZS 3551 standards. Not only does it test to the newest global standards, customers can interface in English, French, German, Spanish, Italian or Portuguese.
With built-in automation, there is no need to carry a laptop for complete automated testing and documentation of electrical safety tests. Quick data entry and error-free reporting reduce test time and improve quality of test results making data management easy.
For more information, visit: www.flukebiomedical.com.