{"product_id":"fda-510k-k100875-cerox-model-321of","title":"FDA 510(k) K100875, CEROX, MODEL 321OF, by Or-Nim Medical , Ltd.","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eCEROX, MODEL 321OF\u003c\/strong\u003e (K100875), submitted by Or-Nim Medical , Ltd..\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K100875\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Oximeter, Tissue Saturation\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Or-Nim Medical , Ltd.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 03\/30\/2010\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 01\/25\/2011\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Number:\u003c\/strong\u003e 870.27\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e MUD\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubsequent Product Code:\u003c\/strong\u003e DPW\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Medical Specialty:\u003c\/strong\u003e Cardiovascular\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e Cardiovascular\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal Pages:\u003c\/strong\u003e 548 (122 unredacted, 77% redacted overall)\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eWhat's in this document\u003c\/strong\u003e (sections may appear in any order):\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e✗ \u003cstrong\u003e510(k) Summary \/ Statement:\u003c\/strong\u003e 85% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e 70% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eDevice Description:\u003c\/strong\u003e 71% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 67% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e 50% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e 87% redacted\u003c\/li\u003e\n\u003cli\u003e✓ \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e 0% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e 30% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e 65% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eClinical Data:\u003c\/strong\u003e 80% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e 30% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e 57% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e 62% redacted\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cem\u003eSection contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.\u003c\/em\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51454813601956,"sku":"FDA510K100875","price":895.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k100875-cerox-model-321of","provider":"FOIA Document Source","version":"1.0","type":"link"}