|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
clinical oxygen dose recorder (codr), model 300-cr
|
INSPIRED TECHNOLOGIES, INC.
|
K082853 |
03/23/2009
|
audicor cpam with sdb (single sensor)
|
INOVISE MEDICAL, INC.
|
K130660 |
10/11/2013
|
audicor ca300/cc100 analyzer with sdb
|
INOVISE MEDICAL, INC.
|
K151433 |
03/18/2016
|
audicor cpam with sdb (cardiopulmonary ambulatory monitor with sleep disordered breathing detection)
|
INOVISE MEDICAL, INC.
|
K120462 |
09/20/2012
|
audicor cpam with sdb (accelerometer based)
|
INOVISE MEDICAL, INC.
|
K131883 |
04/11/2014
|
inomax ds (delivery system)
|
INO THERAPEUTICS LLC
|
K090958 |
06/18/2009
|
sleepstrip disposable apnea screener
|
INFLUENT LTD.
|
K002135 |
12/06/2000
|
apneacheck
|
IM SYSTEMS
|
K022294 |
04/25/2003
|
hc1000p sleep diagnosis software system
|
HYPNOCORE, LTD.
|
K073269 |
04/18/2008
|
simon multichannel recording system, model 5500
|
HEALTHDYNE TECHNOLOGIES, INC.
|
K983572 |
03/19/1999
|