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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 K992323
Device Name DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
Applicant
Datex-Ohmeda., Inc.
3 Highwood Dr.
Tewksburt,  MA  01876
Applicant Contact JOEL C KENT
Correspondent
Datex-Ohmeda., Inc.
3 Highwood Dr.
Tewksburt,  MA  01876
Correspondent Contact JOEL C KENT
Regulation Number870.1025
Classification Product Code
MLD  
Subsequent Product Codes
BZG   BZQ   CBQ   CBR   CBS  
CCI   CCK   CCL   DPS   DQA   DSA  
DSK   DXN   FIL   KOI  
Date Received07/12/1999
Decision Date 11/01/1999
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
Recalls CDRH Recalls
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