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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K042601
Device Name CAPNOSTAT 5
Original Applicant
RESPIRONICS NOVAMETRIX, INC.
5 technology dr.
wallingford,  CT  06492
Original Contact kevin mader
Regulation Number868.1400
Classification Product Code
CCK  
Date Received09/24/2004
Decision Date 11/19/2004
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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