510(k) K103167

STELLAR 150 by Resmed Germany, Inc. — Product Code MNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2011
Date Received
October 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sv70 Ventilator
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type