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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K974101
Device Name DATEX-ENGSTROM NETWORK
Applicant
Datex-Engstrom, Inc.
2 Highwood Dr.
Tewksbury,  MA  01876
Applicant Contact JOEL KENT
Correspondent
Datex-Engstrom, Inc.
2 Highwood Dr.
Tewksbury,  MA  01876
Correspondent Contact JOEL KENT
Regulation Number870.2300
Classification Product Code
MSX  
Date Received10/30/1997
Decision Date 02/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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