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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 K873396
Device Name KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281
Applicant
KONTRON INSTRUMENTS, INC.
9 PLYMOUTH ST.
EVERETT,  MA  02149
Applicant Contact DAVID CROMWICK
Correspondent
KONTRON INSTRUMENTS, INC.
9 PLYMOUTH ST.
EVERETT,  MA  02149
Correspondent Contact DAVID CROMWICK
Regulation Number868.1400
Classification Product Code
CCK  
Date Received08/24/1987
Decision Date 06/21/1988
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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