{"product_id":"fda-510k-k203768","title":"FDA 510(k) K203768, Omnipod 5 ACE Pump (Pod), by Insulet Corporation","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eAlternate Controller Enabled Insulin Infusion Pump\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK203768\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Omnipod 5 ACE Pump (Pod)\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Insulet Corporation\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e880.5730\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eQFG\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e12\/23\/2020\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 01\/27\/2022\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eClinical Chemistry\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eClinical Chemistry\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 103,460\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 101,162\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 2,298\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51309545193636,"sku":"FDA510K203768","price":3500.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k203768","provider":"FOIA Document Source","version":"1.0","type":"link"}