To see if your product may classify as a class II device, visit the FDA device classification guidancesite.
要想确认你的产品是否为II类医疗器械,可以查阅fda的器械分类指导网站。
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This publishes the Web site with all of the process information (tasks, roles, work products, and guidance) so it can be accessed by members of the team.
Because most UNIX and Linux users are savvy enough to get and install software without any guidance from me, I'll just direct you to the GNU project site.