OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K021682
Device Name OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC
Original Applicant
OMRON HEALTHCARE, INC.
300 lakeview pkwy.
vernon hills, 
IL 
60061

Original Contact iwao kojima
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 05/22/2002
Decision Date 12/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No