FDA 510(k) Applications Submitted by Nancy DeAngelo

FDA 510(k) Number Submission Date Device Name Applicant
K190560 03/05/2019 SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface Nonin Medical, Inc.
K210833 03/19/2021 Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula Smiths Medical ASD, Inc.
K221381 05/13/2022 KDG Abutments Keystone Dental Inc.
K223814 12/20/2022 Genesis ACTIVE Implant System Keystone Dental Inc.
K160865 03/30/2016 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C S NONIN MEDICAL, INC.


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