Lub Rau Hli 21, 2017, Tuam Tshoj FDA tshaj tawm 14thDaim ntawv ceeb toom ntawm cov cuab yeej kho mob zoo thiab luam tawm kev saib xyuas zoo & cov qauv tshuaj xyuas qhov xwm txheej ntawm 3 pawg 247 teeb tsa cov khoom xws li cov raj siv pov tseg tracheal, kev kho mob hluav taws xob ntsuas kub thiab lwm yam.
Random-kuaj kuaj cov qauv uas tsis ua raws li cov qauv ntawm cov khoom siv kho mob uas muaj 3 pawg 4 teev cov khoom tsim los ntawm 4 cov khoom siv kho mob;soj ntsuam cov khoom xws li daim ntawv cim npe, daim ntawv qhia thiab lwm yam tsis ua raws li cov qauv yog 1 qeb 2 teev cov khoom siv kho mob uas tsim los ntawm 2 cov tuam txhab kho mob;3 pawg 241 teeb tsa cov cuab yeej kho mob tsim los ntawm 92 cov tuam txhab kho mob ua tau raws li cov qauv tsim nyog rau txhua yam khoom kuaj.
Tam sim no, National Food and Drug Administration twb tau thov cov zaub mov thiab tshuaj saib xyuas hauv zos thiab cov thawj coj saib xyuas thiab cuam tshuam nrog cov lag luam uas cuam tshuam, thiab tau hais kom cov koom haum saib xyuas zaub mov thiab tshuaj yeeb hauv lub xeev tau tshaj tawm cov xwm txheej pov tseg rau pej xeem. .
Txhawm rau ntxiv dag zog rau kev saib xyuas zoo thiab kev tswj xyuas cov cuab yeej kho mob thiab xyuas kom muaj kev nyab xeeb thiab siv tau zoo ntawm cov cuab yeej kho mob, peb lub teb chaws FDA tsis ntev los no ua kev saib xyuas zoo thiab kev kuaj xyuas nruj raws li qhov ntau zaus mus rau qhov nruab nrab ntawm 2 zaug hauv ib hlis.Nws tag nrho embodies qhov kev txhawj xeeb ntawm tsoom fwv rau cov khoom siv kho mob, nws yuav tsum tau sawv qhov kev xeem ntawm lub khw yog tias koj xav mus rau txoj kev no mus deb.
Shenzhen Med-link Medical Electronics Co., Ltd. ib txwm xav kom txhua yam khoom kom tau raws li cov qauv tshiab hauv tebchaws thiab thoob ntiaj teb.Txij li thaum nws tau tsim nyob rau hauv 2004, tom qab 1 xyoo kev npaj, Med-link thawj pawg ntawm ECG cable thiab cov hlau lead hlau dhau CFDA kev tso npe ua tiav, nws yog qhov pib zoo thiab tseem yog qhov pov thawj zoo tshaj plaws ntawm peb cov kev siv zog.
Tom qab 13 xyoo kev tshawb fawb tshiab hauv kev kho mob ntawm cov khoom siv kho mob los ntawm 2017, Med-link tus kheej tsim kev ntsuas kub, rov siv tau SpO2 sensor, siv ESU mem hluav, mem tes SpO2 txuas ntxiv cable, tsis muaj lub hlwb electrode, IBP cable thiab lwm yam, tag nrho cov no series ntawm Cov khoom lag luam tau lees paub los ntawm cov koom haum thoob ntiaj teb xws li CFDA, FDA, CE thiab lwm yam.
Nrog rau kev sim ntev hauv kev lag luam khoom siv kho mob, peb yuav tsis ua rau yav dhau los, thiab tseem yuav tsis yooj yim los ntawm kauj ruam.Kev kho kom haum rau kev hloov pauv khoom siv kho mob tas li, ua tau raws li qhov xav tau ntawm cov pab pawg sib txawv, Med-link Medical yuav ua raws li cov qauv siab & cov cuab yeej siv siab, thiab ua pov thawj peb lub zog nrog cov khoom zoo.
Txuas kev saib xyuas lub neej nrog kev saib xyuas, ua rau cov neeg ua haujlwm kho mob yooj yim dua, tib neeg noj qab nyob zoo!
Post lub sij hawm: Aug-28-2017