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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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