TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING


Device Classification Name

monitor, heart rate, fetal, ultrasonic

510(k) Number K010920
Device Name TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
Original Applicant
MEDICAL CABLES, INC.
1340 logan ave.
costa mesa, 
CA 
92626

Original Contact robert hilman
Regulation Number 884.2660
Classification Product Code
HEL  
Subsequent Product Code
HFM  
Date Received 03/27/2001
Decision Date 06/22/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Traditional
Reviewed by Third Party No

Combination Product

No