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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 K893770
Device Name TERM GUARD II DEVICE
Applicant
Tokos Medical Corp.
1821 E. Dyer Rd.
Suite 200
Santa Ana,  CA  92705
Applicant Contact PENNI PANNELL
Correspondent
Tokos Medical Corp.
1821 E. Dyer Rd.
Suite 200
Santa Ana,  CA  92705
Correspondent Contact PENNI PANNELL
Regulation Number884.2720
Classification Product Code
HFM  
Date Received05/22/1989
Decision Date 11/03/1989
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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