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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
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