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FDA 510(k) Applications Submitted by Colleen Witt
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140268
02/12/2014
SIMPLE T YOUTH NASAL MASK
RESPIRONICS, INC.
K140580
03/06/2014
REVOLUTION FULLFACE MASK
RESPIRONICS INC. (DBA PHILIPS RESPIRONICS)
K181166
05/02/2018
Trilogy Evo
Respironics Inc.
K181170
05/02/2018
Trilogy Evo Universal
Respironics Inc.
K161411
05/20/2016
Care Cycle Connect Application
RESPIRONICS, INC.
K121955
07/03/2012
COUGHASSIST T70 DEVICE
RESPIRONICS, INC.
K132168
07/12/2013
BRONCHOSCOPY ELBOW
RESPIRONICS, INC.
K122111
07/17/2012
RESPIRONICS SIMPLYCLEAR DEVICE
RESPIRONICS, INC.
K152356
08/20/2015
Sapphire
RESPIRONICS INC.
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