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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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