{"product_id":"fda-510k-k242152","title":"FDA 510(k) K242152, SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141), by Epic Medical Pte. , Ltd.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003ePump, Infusion, Elastomeric\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK242152\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Epic Medical Pte. , Ltd.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e880.5725\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eMEB\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e07\/23\/2024\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 10\/07\/2024\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eGeneral Hospital\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eGeneral Hospital\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 396\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 186\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 210\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313334911140,"sku":"FDA510K242152","price":699.72,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k242152","provider":"FOIA Document Source","version":"1.0","type":"link"}