Published on: 2023-01967. Final amendment; final order. 2023-01967. Medical Devices; Cardiovascular Devices; Classification of the Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate
Published on: 2023-00010. Final amendment; final order. 2023-00010. Medical Devices; Cardiovascular Devices; Classification of the Hardware and Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate
Published on: 2022-28168. Final amendment; final order. 2022-28168. Medical Devices; Cardiovascular Devices; Classification of the Extracorporeal System for Carbon Dioxide Removal
Published on: 2022-28173. Final amendment; final order. 2022-28173. Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device
Published on: 2022-28131. Final amendment; final order. 2022-28131. Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Hemodynamic Indicator With Decision Point
Published on: 2022-12364. Final amendment; final order. 2022-12364. Medical Devices; Cardiovascular Devices; Classification of the Intravascular Bleed Monitor
Published on: 2022-11699. Final amendment; final order. 2022-11699. Medical Devices; Cardiovascular Devices; Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals