|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
dreamwear silicone pillows mask
|
Respironics, Inc.
|
K210844 |
08/24/2021
|
magneto nasal mask
|
Respironics, Inc.
|
K210386 |
07/12/2021
|
ventilator, non-continuous (respirator)
|
Respironics, Inc.
|
K201439 |
09/25/2020
|
dreamstation 2 system, dreamstation 2 advanced system
|
Respironics, Inc.
|
K200480 |
07/10/2020
|
simple t pediatric nasal mask
|
RESPIRONICS, INC.
|
K151120 |
04/15/2016
|
af541 ee full face mask
|
RESPIRONICS, INC.
|
K150639 |
09/18/2015
|
ti nasal mask
|
RESPIRONICS, INC.
|
K140980 |
02/10/2015
|
revolution full face mask
|
Respironics, Inc.
|
K142554 |
01/09/2015
|
simple t youth nasal mask
|
RESPIRONICS, INC.
|
K140268 |
10/20/2014
|
bronchoscopy elbow
|
RESPIRONICS, INC.
|
K132168 |
11/20/2013
|
|