PER 2000 News
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In November 2009 the manufacturer of the PER 2000 received the final report of the notified body TUV Sud in San Diego. The main message of this report was that Pulsed Energy Technologies is now certified as a manufacturer of medical devices by ISO 13485. See the document by clicking the page certifications.
This certification is the basic precondition to apply for the CE approval. We passed all tests already (CE, EMC, security etc.) with positive results in compliance with the european directives MPG 93/42 and the final meeting with the TÜV in San Diego took place before the end of the year 2009. We expect now to receive the documents for CE approval at least early 2010.
During the examination of the EMC testimonial of the PER 2000 the TUEV detected that one value was a little bit over the default limit. But the guide line for the European approval contains an exception for such devices that produce a magnetic field. Our PER 2000 belongs definitely to this category. We engaged an appraiser for medival devices to clear this situation with the TUEV. We expect now a positive result soon.
18. April 2010 - breaking news
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