WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K121355
Device Name WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Applicant
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
west lake economy & technology
zone
hangzhou, zhejiang, 

CN

310030

Applicant Contact ren yunhua
Correspondent
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
west lake economy & technology
zone
hangzhou, zhejiang, 

CN

310030

Correspodent Contact ren yunhua
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 05/04/2012
Decision Date 07/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No