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510(k) K102465

BIPAP AVAPS VENTILATORY SUPPORT SYSTEM by Respironics, Inc. — Product Code MNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2011
Date Received
August 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Non-Life-Supporting
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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