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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, pulmonary function data
510(k) Number K982499
Device Name COSMO PLUS WITH NICO, MODEL 8200
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
56 CARPENTER LN.
WALLINGFORD,  CT  06492
Applicant Contact ROBERT H SCHIFFMAN
Correspondent
NOVAMETRIX MEDICAL SYSTEMS, INC.
56 CARPENTER LN.
WALLINGFORD,  CT  06492
Correspondent Contact ROBERT H SCHIFFMAN
Regulation Number868.1880
Classification Product Code
BZC  
Date Received07/20/1998
Decision Date 10/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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