|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
watch-pat 200s-3 (wp200s-3)
|
ITAMAR MEDICAL LTD
|
K102567 |
06/02/2011
|
apnea risk evaluation system (ares)
|
ADVANCED BRAIN MONITORING INC.
|
K110705 |
04/14/2011
|
snap model 8 snoring and apnea recording and analysis system
|
SNAP DIAGNOSTICS, L.L.C.
|
K110064 |
03/18/2011
|
be micro, trea
|
EB NEURO, S.P.A.
|
K093728 |
04/29/2010
|
nomad sleep system recorder, model pmu800
|
NEUROTRONICS, INC.
|
K092699 |
03/18/2010
|
cpc sleep data recorder, model m1, and application software
|
MyCardio, LLC
|
K092003 |
09/30/2009
|
alice pdx
|
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
|
K090484 |
06/26/2009
|
inomax ds (delivery system)
|
INO THERAPEUTICS LLC
|
K090958 |
06/18/2009
|
clinical oxygen dose recorder (codr), model 300-cr
|
INSPIRED TECHNOLOGIES, INC.
|
K082853 |
03/23/2009
|
apnealink plus, model: 22328
|
RESMED GERMANY INC.
|
K083575 |
03/19/2009
|