BABYCARE


Device Classification Name

monitor, blood-flow, ultrasonic

510(k) Number K023082
Device Name BABYCARE
Original Applicant
BIONET COMPANY LTD
1308 morningside park dr.
alpharetta, 
GA 
30022

Original Contact jay mansour
Regulation Number 884.2660
Classification Product Code
HEP  
Date Received 09/17/2002
Decision Date 03/03/2003
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