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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, St Segment With Alarm
510(k) Number K953175
Device Name AS/3 ESTPR MODULE
Applicant
Datex Division Instrumentarium Corp.
2 Highwood Dr.
Tewksbury,  MA  01876
Applicant Contact VINCENT RAUSHER
Correspondent
Datex Division Instrumentarium Corp.
2 Highwood Dr.
Tewksbury,  MA  01876
Correspondent Contact VINCENT RAUSHER
Regulation Number870.1025
Classification Product Code
MLD  
Date Received07/07/1995
Decision Date 02/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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