|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
matrx plus
|
Zephyr Sleep Technologies
|
K181996 |
11/21/2018
|
serenity piezo sensor, serenity thermocouple sensor
|
Neurotronics, Inc.
|
K181709 |
11/16/2018
|
watch-pat300
|
Itamar Medical, Ltd.
|
K180775 |
08/17/2018
|
star 65
|
Skanray Technologies Pvt Ltd
|
K172147 |
05/25/2018
|
positional sleep assessment system (posas) software
|
Advanced Brain Monitoring
|
K172799 |
03/09/2018
|
tempus pro patient monitor
|
Remote Diagnostic Technologies Ltd.
|
K173768 |
01/10/2018
|
zmachine synergy
|
Consolidated Research of Richmond, Inc. dba General Sleep Co
|
K172986 |
12/19/2017
|
sleepimage system
|
MyCardio, LLC dba SleepImage.
|
K163696 |
10/13/2017
|
matrx plus
|
Zephyr Sleep Technologies
|
K163665 |
05/05/2017
|
apnea risk evaluation system (ares), model 620
|
Watermark Medical
|
K160499 |
04/24/2017
|