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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K801747
Device Name TERUMO FETAL MONITOR # FHM-602
Applicant
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Regulation Number884.2740
Classification Product Code
HGM  
Date Received07/28/1980
Decision Date 08/13/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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