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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Uterine Contraction, External (For Use In Clinic)
510(k) Number K992811
Device Name TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
Applicant
Epic Medical Equipment Services, Inc.
1800 10th St., Suite 300
Plano,  TX  75074
Applicant Contact KRISTA OAKES
Correspondent
Epic Medical Equipment Services, Inc.
1800 10th St., Suite 300
Plano,  TX  75074
Correspondent Contact KRISTA OAKES
Regulation Number884.2720
Classification Product Code
HFM  
Subsequent Product Code
HEL  
Date Received08/20/1999
Decision Date 01/18/2000
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
Predetermined Change
Control Plan Authorized		 No
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