BLOOD PRESSURE MONITOR


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K112690
Device Name BLOOD PRESSURE MONITOR
Applicant
NIHON SEIMITSU SOKKI CO., LTD.
6-5-3 beaune honkomagome 2f
honkomagome
bunkyo-ku, tokyo, 

JP

113-0021

Applicant Contact koji kubo
Correspondent
NIHON SEIMITSU SOKKI CO., LTD.
6-5-3 beaune honkomagome 2f
honkomagome
bunkyo-ku, tokyo, 

JP

113-0021

Correspodent Contact koji kubo
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 09/15/2011
Decision Date 02/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No