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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intra-Pulmonary Percussive Vibration (Ipv) Devices
510(k) Number K122111
Device Name RESPIRONICS SIMPLYCLEAR DEVICE
Applicant
Respironics, Inc.
1740 Golden Mile Highway
Murrysville,  PA  15146
Applicant Contact COLLEEN WITT
Correspondent
Respironics, Inc.
1740 Golden Mile Highway
Murrysville,  PA  15146
Correspondent Contact COLLEEN WITT
Regulation Number868.5665
Classification Product Code
SDT  
Date Received07/17/2012
Decision Date 12/31/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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