510(k) K082113

NOX T3, NOXTURNAL (PC APPLICATION) by Nox Medical — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2008
Date Received
July 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type