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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 K150639
Device Name AF541 EE Full Face Mask
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LANE
MURRYSVILLE,  PA  15668
Applicant Contact Shaylee Masilunas
Correspondent
RESPIRONICS, INC.
1001 MURRY RIDGE LANE
MURRYSVILLE,  PA  15668
Correspondent Contact Shaylee Masilunas
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/11/2015
Decision Date 09/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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