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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 K964239
Device Name COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER
Applicant
Spegas Industries, Ltd.
70 Walnut St.
Wellesley,  MA  02181
Applicant Contact YACOV BUBIS
Correspondent
Spegas Industries, Ltd.
70 Walnut St.
Wellesley,  MA  02181
Correspondent Contact YACOV BUBIS
Regulation Number868.1400
Classification Product Code
CCK  
Date Received10/23/1996
Decision Date 05/09/1997
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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