VANTAGE ABI


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K103693
Device Name VANTAGE ABI
Applicant
SUMMIT DOPPLER SYSTEMS, INC.
4680 table mountain dr #150
golden, 
CO 
80403

Applicant Contact ken jarrell
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 12/17/2010
Decision Date 02/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No