LIFEDOP DOPPLER


Device Classification Name

monitor, ultrasonic, fetal

510(k) Number K024197
Device Name LIFEDOP DOPPLER
Original Applicant
SUMMIT DOPPLER SYSTEMS, INC.
5350 vivian st., suite a
arvada, 
CO 
80002 -1957

Original Contact ken jarrell
Regulation Number 884.2660
Classification Product Code
KNG  
Subsequent Product Code
HEP  
Date Received 12/20/2002
Decision Date 01/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No