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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 K853856
Device Name EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET
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 Received09/16/1985
Decision Date 03/12/1986
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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