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Entreprise · 15/06/20111 min de lecture
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction Hearing Aid
Traduction automatique locale · Langue originale de la source
Résumé
The Food and Drug Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). 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.
Langue originale de la source: Federal Register — Health and Human ServicesOuvrir le communiqué original →