{"product_id":"fda-510k-k221052","title":"FDA 510(k) K221052, Self-Fitting hearing aids, by Huizhou Jinghao Medical Technology Co., Ltd.","description":"\u003ctable\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e510(k) Number\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eK221052\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eDevice Classification Name\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eSelf-Fitting Air-Conduction Hearing Aid, Over The Counter\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eDevice Name\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eSelf-Fitting hearing aids\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eApplicant\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eHuizhou Jinghao Medical Technology Co., Ltd. Floor 6, Huicheng Industry Bldg., #9 Huifeng Dong'Er Rd. Zhongkai High-Tech Zone Huizhou, CN 516006\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eRegulation Number\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e874.3325\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eClassification Product Code\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eQUH\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eDate Received\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e04\/11\/2022\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eDecision Date\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e09\/25\/2023\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eDecision\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eSubstantially Equivalent (SESE)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eRegulation Medical Specialty\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eEar Nose \u0026amp; Throat\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e510k Review Panel\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eEar Nose \u0026amp; Throat\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eType\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eTraditional\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eReviewed by Third Party\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eNo\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eCombination Product\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eNo\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eTotal Pages\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e3509\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eRedacted Pages\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e2872\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eUnredacted Pages\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e637\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51307147198628,"sku":"FDA510K221052","price":1569.51,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k221052","provider":"FOIA Document Source","version":"1.0","type":"link"}