{"product_id":"fda-510k-k241799-atmos-c-051-thorax-317-0200-0-secretion-canister-800ml-317-1300-0-hose-system-312-1177-0-et-al","title":"FDA 510(k) K241799, ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0) et al","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C\u003c\/strong\u003e (K241799), submitted by Atmos Medizintechnik GmbH \u0026amp; Co. KG.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K241799\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Pump, Portable, Aspiration (Manual Or Powered)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Atmos Medizintechnik GmbH \u0026amp; Co. KG\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 06\/21\/2024\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 03\/07\/2025\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Number:\u003c\/strong\u003e 878.478\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e BTA\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Medical Specialty:\u003c\/strong\u003e General \u0026amp; Plastic Surgery\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e General \u0026amp; Plastic Surgery\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal Pages:\u003c\/strong\u003e 5820 (2166 unredacted, 62% redacted overall)\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eWhat's in this document\u003c\/strong\u003e (sections may appear in any order):\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Summary \/ Statement:\u003c\/strong\u003e 75% redacted\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIndications for Use:\u003c\/strong\u003e 76% redacted\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Description:\u003c\/strong\u003e 82% redacted\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 74% redacted\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e 93% redacted\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e 78% redacted\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e 88% redacted\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e 74% redacted\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e 76% redacted\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eClinical Data:\u003c\/strong\u003e 80% redacted\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e 27% redacted\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e 75% redacted\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e 76% redacted\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cem\u003eSection contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.\u003c\/em\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51457360527524,"sku":"FDA510K241799","price":299.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k241799-atmos-c-051-thorax-317-0200-0-secretion-canister-800ml-317-1300-0-hose-system-312-1177-0-et-al","provider":"FOIA Document Source","version":"1.0","type":"link"}