ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K001671
Device Name ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
Original Applicant
OMRON HEALTHCARE, INC.
300 lakeview pkwy.
vernon hills, 
IL 
60061

Original Contact osamu shirasaki
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 06/01/2000
Decision Date 06/30/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No