|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
embletta mpr
|
EMBLA SYSTEMS
|
K122516 |
02/21/2013
|
audicor cpam with sdb (cardiopulmonary ambulatory monitor with sleep disordered breathing detection)
|
INOVISE MEDICAL, INC.
|
K120462 |
09/20/2012
|
capnostream20p with ai/odi
|
ORIDION MEDICAL 1987 LTD.
|
K112368 |
07/19/2012
|
apnea risk evaluation system (ares)
|
ADVANCED BRAIN MONITORING, INC.
|
K112514 |
01/09/2012
|
sleepstrip ii
|
S.L.P LTD.
|
K112822 |
12/27/2011
|
michele sleep scoring systems
|
YOUNES SLEEP TECHNOLOGIES
|
K112102 |
12/20/2011
|
mdrive
|
EMBLA SYSTEMS
|
K111742 |
08/31/2011
|
morpheus ox
|
WIDEMED LTD
|
K111314 |
08/31/2011
|
accusom
|
NOVASOM, INC.
|
K110486 |
08/12/2011
|
apnea risk evaluation system (ares)
|
ADVANCED BRAIN MONITORING, INC.
|
K111194 |
07/07/2011
|