{"product_id":"fda-510k-k241612-video-bronchoscope-system-single-use-flexible-bronchoscope-bc-s1e00-l-bc-s1h00-l-bc-s1j00-l-bc-s1e00-bc-s1h00-bc-s1j00-digital-video-monitor-dvm-d1-dvm-d2","title":"FDA 510(k) K241612, Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2), by Hunan Vathin Medical Instrument Co., Ltd.","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eVideo Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)\u003c\/strong\u003e (K241612), submitted by Hunan Vathin Medical Instrument Co., Ltd..\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K241612\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Bronchoscope (Flexible Or Rigid)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Hunan Vathin Medical Instrument Co., Ltd.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 06\/05\/2024\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 10\/29\/2024\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 874.468\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e EOQ\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Medical Specialty:\u003c\/strong\u003e Ear Nose \u0026amp; Throat\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e Ear Nose \u0026amp; Throat\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal Pages:\u003c\/strong\u003e 4486 (3674 unredacted, 18% redacted overall)\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eWhat's in this document\u003c\/strong\u003e (sections may appear in any order):\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e✗ \u003cstrong\u003e510(k) Summary \/ Statement:\u003c\/strong\u003e 100% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e 72% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eDevice Description:\u003c\/strong\u003e 73% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 71% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e 70% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e 84% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e 82% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e 45% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e 77% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eClinical Data:\u003c\/strong\u003e 100% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e 50% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e 66% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e 71% redacted\u003c\/li\u003e\n\u003c\/ul\u003e\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":51454814421156,"sku":"FDA510K241612","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-k241612-video-bronchoscope-system-single-use-flexible-bronchoscope-bc-s1e00-l-bc-s1h00-l-bc-s1j00-l-bc-s1e00-bc-s1h00-bc-s1j00-digital-video-monitor-dvm-d1-dvm-d2","provider":"FOIA Document Source","version":"1.0","type":"link"}