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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.
TEWKSBURY,  MA  01876
Applicant Contact JOEL C KENT
Correspondent
DATEX-OHMEDA, INC.
3 HIGHWOOD DR.
TEWKSBURY,  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
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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