Maikutlo: 0 Mongoli: Nako ea Phatlalatso ea Mohlophisi oa Sebaka: 2025-07-04 Tšimoloho: Sebaka
Re thabela ho phatlalatsa hore rona compressor nebulizer mefuta - NB-1100, NB-1101, NB-1102 , le NB-1103 - ba amohetse semmuso tumello ea FDA 510(k) tlasa Khoutu ea Sehlahisoa CAF.
Tumello ena e bontsha ho dumellana le ditlhoko tse thata tsa taolo ya US, e netefatsang hore disebediswa tsa rona di lekana haholo ka polokeho le katleho ho dihlahiswa tse rekisitsweng ka molao United States.
Letoto la NB-1100 le etselitsoe ho fana ka kalafo e tšepahalang ea phefumoloho 'me le etsa liteko tse ngata tsa ts'ebetso ho netefatsa tlhahiso e tsitsitseng ea aerosol le litekanyetso tse tsitsitseng tsa nebulization. Sena se thusa meriana hore e fihle hantle karolong e tlaase ea phefumoloho bakeng sa liphello tse molemo tsa phekolo.
Tšireletseho ea mokuli e bohlokoa mosebetsing oa rona. Lisebelisoa tsohle tse amanang le meriana kapa bakuli li etsoa litekong tse matla tsa biocompatibility, ho netefatsa boiketlo le polokeho. Ntle le moo, li-nebulizer tsa rona li etsa tlhahlobo ea polokeho ea motlakase le ho lumellana ha motlakase, ho netefatsa ts'ebetso e tšepahalang maemong a kliniki le a lapeng.
Re utloisisa bohlokoa ba bohloeki. Letoto la NB-1100 le netefalitsoe bakeng sa lits'ebetso tse sebetsang tsa ho hloekisa le ho bolaea likokoana-hloko, ho boloka ts'ebetso e tšepahalang ntle le ho sekisetsa..
Ho fihlella tumello ea FDA 510(k) tlasa Khoutu ea Sehlahisoa CAF ho nolofalletsa letoto la NB-1100 ho kena mebarakeng ea lefats'e, ho fa balekane ba rona le basebelisi ba lefats'e ka bophara tšepo ea boleng bo tšepahalang, ho latela melao le khotso ea kelello.
Tšepa moea o mong le o mong-ka Joytech NB-1100 Series.