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The B4C System is cleared under FDA 510k numbers K201989 | K240821.
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3.4.2 biocompatibility
Sensors BcSs-PICNIW-1000 and BcSs-PICNIW-2000 have passed biocompatibility tests in accordance with standards NBR IEC 60601-1, ISO 10993-10:2010, EN ISO 10993-10:2013 e ISO 10993-5:2009..
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