SURESIGNS VSI VITAL SIGNS MONITOR


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K110803
Device Name SURESIGNS VSI VITAL SIGNS MONITOR
Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Applicant Contact mary kruitwagen
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Correspodent Contact mary kruitwagen
Regulation Number 870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQA   FLL  
Date Received 03/23/2011
Decision Date 05/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No