Medical Device AOC是指“美国食品药品监督管理局（FDA）认可的医疗器械委托人”。在美国FDA清关流程中，涉及医疗器械的进口商需要获得Medical Device AOC以便顺利清关。这一认证表明进口商已经通过了FDA的审核，符合其相关规定。医疗器械在美国的清关过程需要遵循严格的法规和规定，以确保产品的安全性和合规性。以下是一...
Why you need to choose us as your FDA 510k consultants? ISOplan USA have successfully prepared submissions for medical device and IVD (In Vitro Diagnostics) companies worldwide. Our approach is the most efficient and cost effective, since it dramatically increases the probability of a successful su...
一、注册产品概况(一)产品及企业信息1.产品基础信息 产品名称: Disposable Insulin Pen Needle k号: K222739 批准日期: 2023-04-06 申请企业: Hantech Medical Device Co., Ltd. 所在国家或地区: 中国 产品分类码:…
October2010;http://www.advamed.org/MemberPortal/About/NewsRoom/NewsReleases/PR-FDA510K-10810.htr. Accessed November 9, 2010 17. Medical Device Industry Applauds Lawmaker Concern Over Review Process. CQ Healthbeat News October13 2010;Google Scholar 18. Federal Register, Medical device user fee...
M. Elizabeth BiermanMichele L. Buenafe
IV Cannula - Infusion products and Intravenous Systems - Surgical blades and devices - Respiratory Care - Blood Transfusion - Urology - Gynecology -medical device - Gastroenterology IV catheter - Medical disposables - IV cannula manufacturing - dis
October2010;http://www.advamed.org/MemberPortal/About/NewsRoom/NewsReleases/PR-FDA510K-10810.htr. Accessed November 9, 2010 17. Medical Device Industry Applauds Lawmaker Concern Over Review Process. CQ Healthbeat News October13 2010;Google Scholar 18. Federal Register, Medical device user fee...
Discover how KomodoSec streamlined cybersecurity compliance for a medical device manufacturer, efficiently addressing vulnerabilities and achieving FDA 510(k) approval.
IV Cannula - Infusion products and Intravenous Systems - Surgical blades and devices - Respiratory Care - Blood Transfusion - Urology - Gynecology -medical device - Gastroenterology IV catheter - Medical disposables - IV cannula manufacturing - dis
产品名称: Aurolase Therapy, Laser Delivery Device (LDD)K号: K202953申请企业: Nanospectra Biosciences, Inc.国家或地区: 美国申请日期: 09/30/2020批准日期: 10/03/2022耗时(天): 733产品预期用途: The Aurolase Therapy, Laser Delivery Device is a fiber-optical laser delivery device to be used wi...