|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
nomadair pmu810
|
Neurotronics, Inc.
|
K220631 |
07/15/2022
|
nomad sleep system recorder, model pmu800
|
NEUROTRONICS, INC.
|
K092699 |
03/18/2010
|
suzanne
|
NELLCOR PURITAN BENNETT, INC.
|
K990565 |
08/18/1999
|
sleepwizard
|
NELLCOR PURITAN BENNETT, INC.
|
K964494 |
02/04/1997
|
modification to suzanne portable polysomnograph system
|
NELLCOR PURITAN BENNETT (MELVILLE) LTD.
|
K030611 |
03/24/2003
|
sleepimage system
|
MyCardio, LLC dba SleepImage.
|
K163696 |
10/13/2017
|
sleepimage system
|
MyCardio, LLC dba SleepImage.
|
K182618 |
08/14/2019
|
cpc sleep data recorder, model m1, and application software
|
MyCardio, LLC
|
K092003 |
09/30/2009
|
microelectroencephalography professional system 5000 (eeg pro system 5000)
|
MICRORECORDING SYSTEMS CONSULTANTS, LLC.
|
K991077 |
06/09/1999
|
compass f10 system
|
MEDCARE FLAGA
|
K041904 |
09/07/2004
|