FDA 510(k) Applications Submitted by Respironics Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K181053 04/20/2018 Care Orchestrator Respironics Inc.
K181166 05/02/2018 Trilogy Evo Respironics Inc.
K181170 05/02/2018 Trilogy Evo Universal Respironics Inc.
K152356 08/20/2015 Sapphire RESPIRONICS INC.
K111885 07/01/2011 SIMPLYGO PORTABLE OXYGEN CONCENTRATOR RESPIRONICS INC.
K120145 01/18/2012 SIMPLE T NASAL MASK RESPIRONICS INC.
K122847 09/18/2012 KANGAROO NASAL MASK RESPIRONICS INC.
K183226 11/20/2018 Care Orchestrator Essence Respironics Inc.
K231313 05/05/2023 Therapy Mask 3100 NC/SP Respironics Inc.
K102985 10/07/2010 V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS Respironics Inc.


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