FDA 510(k) Applications Submitted by Sindura Penubarthi

FDA 510(k) Number Submission Date Device Name Applicant
K180046 01/08/2018 Masimo Rad-97 and Accessories Masimo Corporation
K201432 06/01/2020 Masimo O3 Regional Oximeter System Masimo Corporation
K182429 09/06/2018 Masimo O3 Regional Oximeter System Masimo Corporation
K182887 10/15/2018 Masimo Rad-67 Pulse CO-Oximeter and Accessories Masimo Corporation
K203113 10/15/2020 Masimo SedLine Sedation Monitor and Accessories Masimo Corporation
K203215 11/02/2020 Radius T wearable thermometer Masimo Corporation
K193242 11/25/2019 Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories Masimo Corporation
K183697 12/31/2018 Masimo Rad-97 and Accessories Masimo Corporation


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