|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
flochannel
|
CHAD THERAPEUTICS, INC.
|
K081176 |
07/28/2008
|
snap model 7 snoring and apnea recording and analysis system
|
SNAP LABORATORIES, L.L.C.
|
K080321 |
05/23/2008
|
apnealink plus, model: 22328
|
RESMED GERMANY INC.
|
K083575 |
03/19/2009
|
apneicare connection center/internet analysis
|
APNEICARE, LLC
|
K082968 |
01/02/2009
|
holter lx analysis
|
NORTH EAST MONITORING INC.
|
K081861 |
12/04/2008
|
nox t3, noxturnal (pc application)
|
NOX MEDICAL
|
K082113 |
11/07/2008
|
alice pdx
|
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
|
K090484 |
06/26/2009
|
be micro, trea
|
EB NEURO, S.P.A.
|
K093728 |
04/29/2010
|
cpc sleep data recorder, model m1, and application software
|
MyCardio, LLC
|
K092003 |
09/30/2009
|
nomad sleep system recorder, model pmu800
|
NEUROTRONICS, INC.
|
K092699 |
03/18/2010
|
|