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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 K152356
Device Name Sapphire
Applicant
RESPIRONICS INC.
1001 MURRY RIDGE LANE
MURRYSVILLE,  PA  15668
Applicant Contact COLLEEN WITT
Correspondent
RESPIRONICS INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE,  PA  15146
Correspondent Contact COLLEEN WITT
Regulation Number868.5905
Classification Product Code
BZD  
Subsequent Product Codes
CBK   MNS   MNT   NOU  
Date Received08/20/2015
Decision Date 01/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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