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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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