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510(k) K102985

V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS by Respironics, Inc. — Product Code MNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2011
Date Received
October 7, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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