CDRH New Update

The following new items were added to the CDRH web pages on October 18, 2018. Previous CDRH New items can be found on the CDRH New webpage. Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170089, DEN170004, DEN170001, DEN160044, and DEN160006 added) Federal Register: Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System Federal Register: General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use Federal Register: General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application Federal Register: General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device Federal Register: Neurological Devices; Classification of the Thermal Vestibular Stimulator for Headache Federal Register: Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms