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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K103578
Device Name PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
Applicant
Respironics Novametrix, LLC
5 Technology Dr.
Wallingford,  CT  06492
Applicant Contact KEVIN MADER
Correspondent
Respironics Novametrix, LLC
5 Technology Dr.
Wallingford,  CT  06492
Correspondent Contact KEVIN MADER
Regulation Number868.1850
Classification Product Code
BZK  
Date Received12/06/2010
Decision Date 06/02/2011
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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