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510(k) K122111

RESPIRONICS SIMPLYCLEAR DEVICE by Respironics, Inc. — Product Code SDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2012
Date Received
July 17, 2012
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intra-Pulmonary Percussive Vibration (Ipv) Devices
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type

It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.

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