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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K090484
Device Name ALICE PDX
Applicant
Respironics Inc., Sleep & Home Respiratory Group
1001 Murry Ridge Ln
Murrysville,  PA  15668
Applicant Contact ZITA A YURKO
Correspondent
Respironics Inc., Sleep & Home Respiratory Group
1001 Murry Ridge Ln
Murrysville,  PA  15668
Correspondent Contact ZITA A YURKO
Regulation Number868.2375
Classification Product Code
MNR  
Date Received02/25/2009
Decision Date 06/26/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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