ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K021225
Device Name ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
Original Applicant
ROSSMAX INTERNATIONAL LTD.
12f., no.189, kang chien rd.
taipei, 

TW

114

Original Contact michael yeh
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 04/18/2002
Decision Date 05/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No