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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Blood-Pressure
510(k) Number K862455
Device Name MODIFIED CARDIOCAP MONITOR
Applicant
Datex Division Instrumentarium Corp.
C/O Puritan Bennett Corp.
265 Ballardvale St.
Wilmington,  MA  01887
Applicant Contact KAIJA BOOS
Correspondent
Datex Division Instrumentarium Corp.
C/O Puritan Bennett Corp.
265 Ballardvale St.
Wilmington,  MA  01887
Correspondent Contact KAIJA BOOS
Regulation Number870.1110
Classification Product Code
DSK  
Date Received06/27/1986
Decision Date 09/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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