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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 K142554
Device Name Revolution Full Face Mask
Applicant
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Applicant Contact Amy Macevoy
Correspondent
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Correspondent Contact Amy Macevoy
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/11/2014
Decision Date 01/09/2015
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
Recalls CDRH Recalls
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