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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 K980384
Device Name TRIP TONOMETRY CATHETER, 18F
Applicant
DATEX-ENGSTROM, INC.
2 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Applicant Contact JOEL C KENT
Correspondent
DATEX-ENGSTROM, INC.
2 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Correspondent Contact JOEL C KENT
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
CBR   KNT  
Date Received02/02/1998
Decision Date 05/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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