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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 K843011
Device Name TERM GUARD 5000 UTERINE ACTIVITY
Applicant
Tokos Medical Corp.
1200 18 St. Nw
Washington,  DC  20036
Applicant Contact STEVEN A HEIMBERG
Correspondent
Tokos Medical Corp.
1200 18 St. Nw
Washington,  DC  20036
Correspondent Contact STEVEN A HEIMBERG
Regulation Number884.2720
Classification Product Code
HFM  
Date Received07/31/1984
Decision Date 11/01/1984
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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