Muva nje, i-Shinva Medical Instrument Co., Ltd. (ngemuva kwalokhu ebizwa ngokuthi i-SHINVA) ithole ngempumelelo Isitifiketi se-FDA 510(k) se-MOST-T yayo.I-Autoclave, okumaka ukuthi ama-autoclave afanelekile e-SHINVA anokuqinisekiswa kwephasi kanye nekhwalithi yokuthekelisa emhlabeni jikelele, futhi kungokokuqala embonini yasekhaya yokuhlanza amagciwane ukuthola isitifiketi se-FDA 510(k), okuyimpumelelo enkulu kusukela ekuqaleni embonini yokuhlanza amagciwane yase-China.

I-MOST-TI-AutoclaveI-T18/24/45/60/80 iyisisetshenziswa sokuvala inzalo esisheshayo esisebenza ngokuzenzakalelayo esisezingeni eliphezulu futhi esinengcindezi ephezulu sisebenzisa isitimu sokucindezela njengesiphakathi.Isetshenziswa ukunakekelwa kwezempilo kanye nezempilo, ucwaningo lwesayensi kanye namanye amayunithi ukuvala inzaloimishini yezokwelapha, imikhumbi yaselabhorethri, imidiya yamasiko kanye noketshezi olungavaliwe noma amalungiselelo, izinto ezingase zihlangane negazi noma uketshezi lomzimba.

Isitifiketi se-FDA 510(k) salo mkhiqizo sibandakanya uchungechunge lwezifundo eziyinkimbinkimbi zikagesi, ukuphepha, i-EMC, kanye nokuhlolwa kokusebenza kokuvala inzalo.I-EPINTEK Labs ihlinzeka ngesethi egcwele ye-ANSI AAMI ST55:2016 izixazululo zokuhlola umusi we-Table-top kanye nezinsizakalo zokuhlola ukuphepha ne-EMC, isebenzisana ne-R&D ye-SHINVA kanye nethimba lekhwalithi ukuze banqobe uchungechunge lwezinkinga eziyinkimbinkimbi zobuchwepheshe nokuhlola, futhi umbiko wokuhlola ubugcwele ngokugcwele. yamukelwe futhi yagunyazwa yi-FDA 510(k).