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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

·1 个月前·来源:美国 FDA

🤖 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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