OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K112269
Device Name OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE
Applicant
OSTAR MEDITECH CORP.
5f, no. 46-4, min-chiuan rd.
shing-tien dist.
new taipei city, 

TW

231

Applicant Contact steven chang
Correspondent
OSTAR MEDITECH CORP.
5f, no. 46-4, min-chiuan rd.
shing-tien dist.
new taipei city, 

TW

231

Correspodent Contact steven chang
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 08/08/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No