SURESIGNS VS2 VITAL SIGNS MONITOR


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K111114
Device Name SURESIGNS VS2 VITAL SIGNS MONITOR
Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover, 
MA 
01810

Applicant Contact kristen lessard
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover, 
MA 
01810

Correspodent Contact kristen lessard
Regulation Number 870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQA   DSA   DSJ   DSK   DXG  
FLL  
Date Received 04/21/2011
Decision Date 05/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No