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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 K030886
FOIA Releasable 510(k) K030886
Device Name NICO WITH MARS, MODEL 7300
Applicant
RESPIRONICS NOVAMETRIX, INC.
5 TECHNOLOGY DR.
WALLINGFORD,  CT  06492
Applicant Contact MICHAEL MALIS
Correspondent
RESPIRONICS NOVAMETRIX, INC.
5 TECHNOLOGY DR.
WALLINGFORD,  CT  06492
Correspondent Contact MICHAEL MALIS
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
BZK   DQA  
Date Received03/21/2003
Decision Date 10/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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