{"id":3071,"date":"2011-02-07T12:04:27","date_gmt":"2011-02-07T17:04:27","guid":{"rendered":"http:\/\/sciencebusiness.technewslit.com\/?p=3071"},"modified":"2011-02-07T12:04:27","modified_gmt":"2011-02-07T17:04:27","slug":"fda-clearance-granted-for-blood-tissue-monitor","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=3071","title":{"rendered":"FDA Clearance Granted for Blood Tissue Monitor"},"content":{"rendered":"<figure id=\"attachment_998\" aria-describedby=\"caption-attachment-998\" style=\"width: 200px\" class=\"wp-caption alignleft\"><a href=\"http:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2010\/09\/BloodBag_NIH.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-998\" title=\"BloodBag_NIH\" src=\"http:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2010\/09\/BloodBag_NIH.jpg\" alt=\"Blood bag (NIH)\" width=\"200\" height=\"200\" srcset=\"https:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2010\/09\/BloodBag_NIH.jpg 200w, https:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2010\/09\/BloodBag_NIH-150x150.jpg 150w\" sizes=\"auto, (max-width: 200px) 100vw, 200px\" \/><\/a><figcaption id=\"caption-attachment-998\" class=\"wp-caption-text\">(National Institutes of Health)<\/figcaption><\/figure>\n<p>Ornim Inc. in Santa Clarita, California said it <a href=\"http:\/\/www.ornim.com\/uploadImages\/systemFiles\/FOR%20IMMEDIATE%20PRESS%20RELEASE.pdf\">received clearance<\/a> from the U.S. Food and Drug Administration (FDA) to market its the CerOx 3210F monitor. The FDA action, known as a 510(k) clearance, is a pre-market notification required for medical devices to be sold in the U.S.<\/p>\n<p>Ornim says the FDA action clears the CerOx 3210F monitor for use as a non-invasive monitor of blood flow in tissue of adults. The device has already been cleared for for non-invasive monitoring of regional hemoglobin oxygen saturation in the brain or skeletal muscle.<\/p>\n<p>A <a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/HowtoMarketYourDevice\/PremarketSubmissions\/PremarketNotification510k\/default.htm\">510(k) submission<\/a>, named after the applicable section of FDA&#8217;s enabling legislation, demonstrates that the device to be marketed is at least as safe and effective &#8212; substantially equivalent &#8212; to a device that is already legally marketed. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.<\/p>\n<p style=\"text-align: center;\">*\u00a0\u00a0\u00a0\u00a0 *\u00a0\u00a0\u00a0\u00a0 *<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ornim Inc. in Santa Clarita, California said it received clearance from the U.S. Food and Drug Administration (FDA) to market its the CerOx 3210F monitor. The FDA action, known as a 510(k) clearance, is a pre-market notification required for medical devices to be sold in the U.S. Ornim says the FDA action clears the CerOx [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[15,5],"tags":[31,22,77],"class_list":["post-3071","post","type-post","status-publish","format-standard","hentry","category-products","category-regulations","tag-biomedical","tag-fda","tag-medical-device"],"_links":{"self":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/3071","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3071"}],"version-history":[{"count":3,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/3071\/revisions"}],"predecessor-version":[{"id":3074,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/3071\/revisions\/3074"}],"wp:attachment":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3071"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3071"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3071"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}