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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 K140980
FOIA Releasable 510(k) K140980
Device Name TI NASAL MASK
Applicant
Respironics, Inc.
1001 Murry Ridge Ln
Murrysville,  PA  15668
Applicant Contact SHAYLEE MASILUNAS
Correspondent
Respironics, Inc.
1001 Murry Ridge Ln
Murrysville,  PA  15668
Correspondent Contact SHAYLEE MASILUNAS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/16/2014
Decision Date 02/10/2015
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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