{"product_id":"fda-510k-k242604","title":"FDA 510(k) K242604, Helios+ UV-C System, by Preventamed Technologies, Inc. Dba Surfacide Manufacturing","description":"\u003ctable\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e510(k) Number\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eK242604\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\u003eWhole Room Microbial Reduction Device\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eDevice Name\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003eHelios+ UV-C System\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eApplicant\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003ePreventamed Technologies, Inc. Dba Surfacide Manufacturing W226n918 Northmound Dr., Suite 300 Waukesha, WI 53186\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\u003eQXJ\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eDate Received\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e08\/30\/2024\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eDecision Date\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e05\/27\/2025\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\u003eGeneral Hospital\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\u003eGeneral Hospital\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\u003e8492\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eRedacted Pages\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e7199\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eUnredacted Pages\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e1293\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51307147362468,"sku":"FDA510K242604","price":2898.61,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k242604","provider":"FOIA Document Source","version":"1.0","type":"link"}