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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K140580
Device Name REVOLUTION FULLFACE MASK
Applicant
Respironics Inc. (Dba Philips Respironics)
1001 Murry Ridge Ln
Murrysville,  PA  15668
Applicant Contact COLLEEN WITT
Correspondent
Respironics Inc. (Dba Philips Respironics)
1001 Murry Ridge Ln
Murrysville,  PA  15668
Correspondent Contact COLLEEN WITT
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/06/2014
Decision Date 01/16/2015
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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