federal_register: 2015-26658

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2015-26658 Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device Rule The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device 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 coronary vascular physiologic simulation software device'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. 2015-10-21 2015 10 https://www.federalregister.gov/documents/2015/10/21/2015-26658/medical-devices-cardiovascular-devices-classification-of-the-coronary-vascular-physiologic https://www.govinfo.gov/content/pkg/FR-2015-10-21/pdf/2015-26658.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device 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...

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