Nguva pfupi yadarika, Shinva Medical Instrument Co., Ltd. (inozonzi SHINVA) yakabudirira kuwana FDA 510(k) Chitupa cheMOST-T yayo.Autoclave, zvichiratidza kuti ma autoclave eSHINVA akakodzera ane kupasa uye vimbiso yemhando yekutengesa kunze kwenyika, uye ikavezve kekutanga muindasitiri yezvicherwa zvekumba kuwana FDA 510(k) certification, inova budiriro huru kubva mukutanga muindasitiri yeChina inouraya.
MOST-TAutoclaveT18/24/45/60/80 izere otomatiki yakakwirira-tembiricha uye yakakwirira-kumanikidza yekukurumidza sterilization mudziyo uchishandisa pressure steam sepakati.Inoshandiswa nekurapa uye hutano hwehutano, tsvakiridzo yesainzi uye mamwe mayuniti ekuita sterilization yemidziyo yekurapa, midziyo yerabhoritari, midhiya yetsika uye zvinwiwa zvisina kuvharwa kana gadziriro, zvinhu zvinogona kusangana neropa kana mvura yemuviri.
Iyo FDA 510 (k) certification yechigadzirwa ichi inosanganisira akatevedzana akaomarara emagetsi, chengetedzo, EMC, uye sterilization performance performance zvidzidzo uye bvunzo.EPINTEK Labs inopa yakazara seti ye ANSI AAMI ST55: 2016 Tafura-yepamusoro pfuti bvunzo mhinduro uye bvunzo masevhisi ekuchengetedza uye EMC, ichishanda neSHINVA's R&D uye mhando timu kukurira akateedzana akaomesesa ehunyanzvi uye ekuyedza matambudziko, uye mushumo webvunzo waive wakazara. inogamuchirwa uye yakatenderwa neFDA 510 (k).
Nguva yekutumira: Oct-14-2022