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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph
510(k) Number K090483
Device Name SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
andover,  MA  01810 -1099
Applicant Contact larry milana
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
andover,  MA  01810 -1099
Correspondent Contact larry milana
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
CCK   DQA   DXN   FFL  
Date Received02/25/2009
Decision Date 03/20/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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