510(k) K124062

QDC-PRO, AND NOX-RIP by Nox Medical — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2013
Date Received
December 31, 2012
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