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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 K963327
Device Name TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
Applicant
Novametrix Medical Systems, Inc.
1 Barnes Industrial Park Rd.
P.O. Box 690
Wallingford,  CT  06492
Applicant Contact ROBERT H SCHIFFMAN
Correspondent
Novametrix Medical Systems, Inc.
1 Barnes Industrial Park Rd.
P.O. Box 690
Wallingford,  CT  06492
Correspondent Contact ROBERT H SCHIFFMAN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received08/23/1996
Decision Date 11/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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