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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM
Classification Namehome uterine activity monitor
Generic Nameexternal uterine contraction monitor
Regulation Number884.2730
ApplicantMATRIA HEALTHCARE, INC.
PMA NumberP910063
Date Received10/21/1991
Decision Date09/29/1995
Reclassified Date 04/09/2001
Product Code
LQK
Docket Number 96M-0255
Notice Date 10/18/1996
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for carefone home uterine activity monitoring syste, model 2001.
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