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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 K894030
Device Name MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
Applicant
HEALTHDYNE, INC.
1850 PARKWAY PLACE, 12TH FLOOR
MARIETTA,  GA  30067 -8274
Applicant Contact TIM COWART
Correspondent
HEALTHDYNE, INC.
1850 PARKWAY PLACE, 12TH FLOOR
MARIETTA,  GA  30067 -8274
Correspondent Contact TIM COWART
Regulation Number884.2720
Classification Product Code
HFM  
Date Received06/06/1989
Decision Date 01/22/1990
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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