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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 K080652
Device Name MERCURY VCO2 MODULE WITH CAPNOSTAT 5
Applicant
RESPIRONICS NOVAMETRIX LLC
5 TECHNOLOGY DRIVE
WALLINGFORD,  CT  06492
Applicant Contact KEVIN MADER
Correspondent
RESPIRONICS NOVAMETRIX LLC
5 TECHNOLOGY DRIVE
WALLINGFORD,  CT  06492
Correspondent Contact KEVIN MADER
Regulation Number868.1850
Classification Product Code
BZK  
Date Received03/07/2008
Decision Date 06/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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