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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transducer, pressure, intrauterine
Regulation Description Intrauterine pressure monitor and accessories.
Product CodeHFN
Regulation Number 884.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 3
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Protective measure issue 1
No fail-safe mechanism 1
No Known Device Problem 1
Retraction problem 1
Total Device Problems 4

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Utah Medical Products, Inc II Sep-11-2008

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