MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K111652
Device Name MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR
Applicant
MICROLIFE INTELLECTUAL PROPERTY GMBH
55 northern blvd., suite 200
great neck, 
NY 
11021

Applicant Contact susan d goldstein-falk
Correspondent
MICROLIFE INTELLECTUAL PROPERTY GMBH
55 northern blvd., suite 200
great neck, 
NY 
11021

Correspodent Contact susan d goldstein-falk
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 06/13/2011
Decision Date 07/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No