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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 K983864
Device Name ETCO2 VITAL SIGNS MODULE
Applicant
Mennen Medical, Inc.
Kiryat Weizmann Science Park
P.O. Box 102
Rehovot,  IL 76100
Applicant Contact KENNETH RAICHMAN
Correspondent
Mennen Medical, Inc.
Kiryat Weizmann Science Park
P.O. Box 102
Rehovot,  IL 76100
Correspondent Contact KENNETH RAICHMAN
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
MHX  
Date Received11/02/1998
Decision Date 10/08/1999
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
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