|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
qdc-pro, and nox-rip
|
NOX MEDICAL
|
K124062 |
07/10/2013
|
capnostream20p with hifi c02 monitoring
|
ORIDION MEDICAL 1987 LTD.
|
K123690 |
08/05/2014
|
audicor cpam with sdb (cardiopulmonary ambulatory monitor with sleep disordered breathing detection)
|
INOVISE MEDICAL, INC.
|
K120462 |
09/20/2012
|
embletta mpr
|
EMBLA SYSTEMS
|
K122516 |
02/21/2013
|
apnea risk evaluation system (ares)
|
ADVANCED BRAIN MONITORING, INC.
|
K111194 |
07/07/2011
|
sleepstrip ii
|
S.L.P LTD.
|
K112822 |
12/27/2011
|
spacelabs pathfinder sl holter analyzer
|
SPACELABS HEALTHCARE LTD.
|
K110001 |
06/14/2011
|
apnea risk evaluation system (ares)
|
ADVANCED BRAIN MONITORING, INC.
|
K112514 |
01/09/2012
|
capnostream20p with ai/odi
|
ORIDION MEDICAL 1987 LTD.
|
K112368 |
07/19/2012
|
apnea risk evaluation system (ares)
|
ADVANCED BRAIN MONITORING INC.
|
K110705 |
04/14/2011
|