SURESIGNS VS2+ -SURESIGNS VSI


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K112652
Device Name SURESIGNS VS2+ -SURESIGNS VSI
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   DSA   DSJ   DSK   DXG  
FLL  
Date Received 09/12/2011
Decision Date 10/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls