{"product_id":"fda-510k-k211291","title":"FDA 510(k) K211291, Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D, by Fiagon GmbH","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eEar, Nose, And Throat Stereotaxic Instrument\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK211291\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Fiagon GmbH\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e882.4560\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003ePGW\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e04\/28\/2021\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 07\/19\/2021\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eNeurology\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eEar Nose \u0026amp; Throat\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 1,658\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,415\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 243\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313221370020,"sku":"FDA510K211291","price":770.25,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k211291","provider":"FOIA Document Source","version":"1.0","type":"link"}