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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 K092217
Device Name MERCURY VCO2
Original Applicant
RESPIRONICS NOVAMETRIX, INC.
5 technology dr.
wallingford,  CT  06492
Original Contact kevin mader
Regulation Number868.1850
Classification Product Code
BZK  
Subsequent Product Code
CCK  
Date Received07/22/2009
Decision Date 08/21/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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