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FDA 510 (k) Clearance Qhib US Market Access rau Six Joytech DBP Ntxiv Cov Tshuaj Ntshav Siab

Views: 0     Author: Site Editor Publish Time: 2026-09-04 Keeb Kwm: Qhov chaw

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Rau lub caj npab sab sauv tsis siv neeg cov ntshav ntsuas ntshav los ntawm Joytech Healthcare's DBP Plus series tau tso cai FDA 510 (k) tshem tawm raws li K261394, ua kom muaj kev lag luam hauv Asmeskas kev lag luam.

Rau cov khw muag khoom noj qab haus huv thiab cov neeg muag khoom nquag hauv Asmeskas kev lag luam, qhov kev tshem tawm no ntau dua li kev tswj hwm tseem ceeb - nws yog qhov ua tau zoo ntawm kev ua lag luam nkag. Txhua lub cuab yeej tshem tawm tau raug tshuaj xyuas raws li cov cuab yeej siv kho mob Class II thiab pom muaj txiaj ntsig zoo sib xws rau cov khoom lag luam raug cai, nrog rau kev npaj siv los npog cov pej xeem.

Ib qho Cleared Lineup ntawm Rau Cov Qauv Tshiab

DBP Plus series coj 6 tus qauv tshiab rau hauv Joytech Healthcare's US-cleared portfolio: DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, thiab DBP-62E2B Plus.

Txhua tus qauv yog tag nrho tsis siv neeg Lub caj npab ntshav siab ntsuas ntsuas  ua rau ntsuas hauv tsev txhua hnub. Cov koob kuj tseem ua pov thawj kev tswj hwm kab mob - nws cov thawj coj DBP-6186 thiab DBP-6286B tau raug tshem tawm los ntawm FDA hauv 2025  rau cov neeg siv nrog caj npab loj dua, thiab cov tiam Plus txuas ntxiv qhov qub engineering platform rau ntau yam qauv.

Ob Qhov Cuff Loj, Cov Neeg Siv Khoom Siv dav dua

Txhua tus qauv hauv pawg tau teeb tsa nrog ib qho ntawm ob txoj kev xaiv cuff - tus qauv 22-42 cm cuff lossis txuas ntxiv 40-56 cm loj caj npab.

Qhov kev ua ob-cuff no tseem ceeb ua lag luam ntau npaum li kev kho mob. Nws tso cai rau cov khw muag khoom thiab cov neeg yuav khoom los tsim cov khoom loj-nrog rau cov khoom sib txawv los ntawm ib tsev neeg cov khoom lag luam, yog li cov neeg laus uas nws caj npab ntog sab nraum cov qauv cuff ntau yam tsis raug yuam mus rau kev ntsuas kev sib haum xeeb.

Qhov twg Cov Saib Xyuas no haum rau hauv Teb Chaws Asmeskas Portfolio

Rau cov neeg yuav khoom ntsuas DBP Plus series, peb lub ntsiab lus sawv tawm:

  • Tag nrho rau-tus qauv batch yog them los ntawm ib qho FDA 510 (k) clearance, yog li assortment npaj tuaj yeem mus yam tsis muaj ib qho qauv kev cai sib txawv.

  • Ob tus qauv thiab lub caj npab loj cuff versions muaj nyob rau hauv qhov kev tshem tawm.

  • Cov lus qhia txog pej xeem txhawb nqa ntau yam kev faib khoom hauv Asmeskas, suav nrog cov khw muag khoom, e-lag luam, thiab lwm yam kev kho mob.

Cov ntaub ntawv tshem tawm nws tus kheej tuaj yeem raug txheeb xyuas los ntawm cov neeg koom tes thaum lub sijhawm mob siab rau - K261394 cov ntsiab lus tuaj yeem nkag mus rau pej xeem los ntawm FDA cov ntaub ntawv.

Tsim los ntawm Kev Tsim Kho Cov Ntawv Teev Tseg

Qhov kev tshem tawm no ntxiv rau kev ua raws li Teb Chaws Asmeskas cov ntaub ntawv loj hlob ntawm Joytech Healthcare, uas twb suav nrog ua ntej 510 (k) clearances rau cov ntshav ntsuas ntshav thiab ntshav qabzib ntsuas, nrog rau CE kos npe raws li EU MDR, ISO 13485 certification, thiab MDSAP ua raws.

Rau OEM / ODM cov neeg koom tes, cov ntaub ntawv sau tseg ua kom luv luv ntawm kev sib tham ua raws: cov lus nug hloov pauv los ntawm seb cov chaw tsim khoom puas tuaj yeem ua tau raws li Teb Chaws Asmeskas cov cai rau cov qauv teeb tsa haum rau qhov kev zov me nyuam.

Muaj rau Kev Tshaj Tawm thiab OEM / ODM Kev Pabcuam

Joytech Healthcare tam sim no lees txais cov lus nug los ntawm Asmeskas cov chaw muag khoom kho mob, cov neeg xa khoom, thiab cov neeg koom tes nyiam hauv DBP Plus series - suav nrog kev tsim cov ntawv sau ntiag tug, kev ntim khoom, thiab cov ntaub ntawv txhawb nqa rau kev sau npe lag luam.

Hais txog Joytech Healthcare

Joytech Healthcare   yog ib lub chaw tsim khoom ntawm kev kho mob hauv tsev thiab kev saib xyuas kev kho mob, tshwj xeeb hauv kev ntsuas ntshav siab, ntsuas kub, ntsuas pulse oximeters, nebulizers, lub mis twj tso kua mis thiab lwm yam khoom kho mob.

Peb muab OEM / ODM cov cuab yeej kho mob daws teeb meem  rau lub ntiaj teb kev noj qab haus huv hom, distributors, thiab cov neeg koom tes, tsom rau kev tswj hwm, kev ntseeg siab ntawm cov khoom, thiab kev koom tes ntev.

Tiv tauj peb

Txhawm rau thov cov qauv ntsuas, cov ntaub ntawv tshem tawm, lossis cov lus hais rau DBP Plus series, hu rau peb pab neeg ntawm sale14@sejoy.com - lossis xauj tag nrho FDA 510 (k) tshem tawm cov ntshav siab ntsuas kab ntawm peb lub vev xaib.

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