DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K024077
Device Name DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR
Original Applicant
ZEWA, INC.
10438 nw 31st terrace
miami, 
FL 
33172

Original Contact thomas zeindler
Regulation Number 870.1130
Classification Product Code
DXN  
Subsequent Product Code
MNW  
Date Received 12/10/2002
Decision Date 03/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No