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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K853953
Device Name CARDIOCAP MONITOR
Applicant
Instrumentarium Corp.
C/O Puritan-Bennett
265 Ballardvale St.
Wilmington,  MA  01887
Applicant Contact OLLI RIIKKALA
Correspondent
Instrumentarium Corp.
C/O Puritan-Bennett
265 Ballardvale St.
Wilmington,  MA  01887
Correspondent Contact OLLI RIIKKALA
Regulation Number870.2300
Classification Product Code
DRT  
Date Received09/25/1985
Decision Date 06/02/1986
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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