EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K021240
Device Name EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200
Original Applicant
EIKON HEALTHCARE DEVICE CORP.
no 58, fu-chiun st.
hsin-chu city,, 

TW

Original Contact jen ke-min
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 04/18/2002
Decision Date 11/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No