|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
ventilator, non-continuous (respirator)
|
Respironics, Inc.
|
K201439 |
09/25/2020
|
bipap a 30 ventilatory support system
|
RESPIRONICS, INC.
|
K113053 |
02/01/2012
|
bipap avaps ventilatory support system
|
RESPIRONICS, INC.
|
K102465 |
03/24/2011
|
bipap synchrony 2 with af531 full face mask
|
RESPIRONICS, INC.
|
K101130 |
09/02/2010
|
bipap avaps ventilatory support system
|
RESPIRONICS, INC.
|
K092818 |
01/22/2010
|
bipap synchrony 2
|
RESPIRONICS, INC.
|
K092043 |
08/05/2009
|
bipap autosv
|
RESPIRONICS, INC.
|
K063540 |
02/22/2007
|
bipap synchrony
|
RESPIRONICS, INC.
|
K063533 |
02/20/2007
|
bipap harmony ventilatory support system
|
RESPIRONICS, INC.
|
K031656 |
07/30/2003
|
bipap synchrony ventilatory support system with bi-flex
|
RESPIRONICS, INC.
|
K020777 |
03/20/2002
|
|