|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
nox rip belts & cables
|
NOX MEDICAL ehf
|
K151361 |
11/06/2015
|
capnostream 35 portable respiratory monitor
|
ORIDION MEDICAL 1987 LTD.
|
K150272 |
07/17/2015
|
watch-pat200u
|
ITAMAR MEDICAL, LTD.
|
K161579 |
02/24/2017
|
apnea risk evaluation system (ares), model 620
|
Watermark Medical
|
K160499 |
04/24/2017
|
matrx plus
|
Zephyr Sleep Technologies
|
K163665 |
05/05/2017
|
sleepimage system
|
MyCardio, LLC dba SleepImage.
|
K163696 |
10/13/2017
|
menai system
|
ResMed Ltd
|
K160836 |
12/15/2016
|
star 65
|
Skanray Technologies Pvt Ltd
|
K172147 |
05/25/2018
|
xacttrace single use respiratory effort belt system
|
Embla Systems
|
K173793 |
03/01/2019
|
tempus pro patient monitor
|
Remote Diagnostic Technologies Ltd.
|
K173768 |
01/10/2018
|