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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 K962638
Device Name TONOCAP, TC-200 AND ACCESSORY CATHETERS
Applicant
INSTRUMENTARIUM CORP.
2 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Applicant Contact JOEL KENT
Correspondent
INSTRUMENTARIUM CORP.
2 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Correspondent Contact JOEL KENT
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
CBR   KNT  
Date Received07/05/1996
Decision Date 04/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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