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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, heart rate, fetal, ultrasonic
510(k) Number K010920
Device Name TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
Applicant
MEDICAL CABLES, INC.
1340 LOGAN AVE.
COSTA MESA,  CA  92626
Applicant Contact ROBERT HILMAN
Correspondent
MEDICAL CABLES, INC.
1340 LOGAN AVE.
COSTA MESA,  CA  92626
Correspondent Contact ROBERT HILMAN
Regulation Number884.2660
Classification Product Code
HEL  
Subsequent Product Code
HFM  
Date Received03/27/2001
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
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