1.申请函。此部分应包括申请人(或联系人)和企业的基本信息、FDA 510(k)递交的目的、申请上市器械的名称型号和分类资料、进行实质等效比较的产品(Predicate Device)名称及其510(k)号码。
1. Application letter. This part shall include the basic information of the applicant (or contact person) and the enterprise, the purpose of submission of FDA 510 (k), the name, model and classification data of the device applying for listing, the name of the product (predict device) for substantial equivalence comparison and its 510 (k) number.
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13。
Facebook公司将使用Mapillary的技术支持Facebook Marketplace等产品
早间消息,Facebook收购了瑞典地图科技公司Mapillary,后者通过数万贡献者提供的图像来制作最新的沉浸式地图。 …