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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 K882080
Device Name MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.
Applicant
AEQUITRON MEDICAL, INC.
14800 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447 -4834
Applicant Contact ROBERT C SAMEC
Correspondent
AEQUITRON MEDICAL, INC.
14800 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447 -4834
Correspondent Contact ROBERT C SAMEC
Regulation Number884.2720
Classification Product Code
HFM  
Date Received05/17/1988
Decision Date 03/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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