この記事の翻訳を準備しています。それまでの間、英語の原文を表示します。
ビジネス · 2016/10/241 分で読めます
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) is classifying the Eustachian tube balloon dilation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the Eustachian tube balloon dilation system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →