精选法规与标准美国 FDAT1085
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus
🤖 AI 摘要
The Food and Drug Administration (FDA) is classifying the combined acoustic and electrical external stimulation device for the relief of tinnitus into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the combined acoustic and electrical external stimulation device for the relief of tinnitus. We are taking this action because we have determined that classifying the device in
分析模型:rule-based-v3 · 07-09 06:59
评分详情
综合分 85/100
信源权威
95
影响范围
90
时效性
50
合规紧急
75
行业关注
90
Federal Register: FDA Final Rules (最终法规)
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