BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)


Device Classification Name

computer, diagnostic, programmable

510(k) Number K022596
Device Name BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)
Original Applicant
CLOVER HI-TECH INC.
17800 castleton st.
suite 415
city of industry, 
CA 
91748

Original Contact cecilia l yu
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 08/05/2002
Decision Date 01/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No