DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES


Device Classification Name

blood pressure cuff

510(k) Number K080366
Device Name DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
Applicant
ZEFON INTL.
5350 s.w. first ln.
ocala, 
FL 
34474

Applicant Contact scott ryan
Correspondent
ZEFON INTL.
5350 s.w. first ln.
ocala, 
FL 
34474

Correspodent Contact scott ryan
Regulation Number 870.1120
Classification Product Code
DXQ  
Date Received 02/12/2008
Decision Date 06/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No