510(k) K124032

METANEB by Hill-Rom Services Pte, Ltd. — Product Code NHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2013
Date Received
December 28, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Positive Pressure Breathing, Intermittent
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type