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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 K012837
Device Name MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
Applicant
Datex-Ohmeda
86 Pilgrim Rd.
Needham,  MA  02492
Applicant Contact JOEL C KENT
Correspondent
Datex-Ohmeda
86 Pilgrim Rd.
Needham,  MA  02492
Correspondent Contact JOEL C KENT
Regulation Number870.1025
Classification Product Code
MLD  
Date Received08/23/2001
Decision Date 09/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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