GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K022926
Device Name GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100
Original Applicant
GENTEEL TECHNOLOGY CO., LTD.
3892 south america west trail
flaggstaff, 
AZ 
86001

Original Contact jennifer reich
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 08/04/2002
Decision Date 06/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No