HANDYDOP


Device Classification Name

monitor, ultrasonic, fetal

510(k) Number K030466
Device Name HANDYDOP
Applicant
ELCAT, GMBH
1308 morningside park dr.
alpharetta, 
GA 
30022

Applicant Contact jay mansour
Correspondent
ELCAT, GMBH
1308 morningside park dr.
alpharetta, 
GA 
30022

Correspodent Contact jay mansour
Regulation Number 884.2660
Classification Product Code
KNG  
Date Received 02/12/2003
Decision Date 09/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Radiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No