TANGO M2 BLOOD PRESSURE MONITOR


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K122401
Device Name TANGO M2 BLOOD PRESSURE MONITOR
Applicant
SUNTECH MEDICAL, INC.
507 airport boulevard
suite 117
morrisville, 
NC 
27560

Applicant Contact chuck setzer
Correspondent
SUNTECH MEDICAL, INC.
507 airport boulevard
suite 117
morrisville, 
NC 
27560

Correspodent Contact chuck setzer
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 08/07/2012
Decision Date 11/02/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No