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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device oximeter, tissue saturation
Regulation Description Oximeter.
Product CodeMUD
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
HUTCHINSON
  SUBSTANTIALLY EQUIVALENT 8
HYPERMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MOOR INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
NONIN
  SUBSTANTIALLY EQUIVALENT 4
OR-NIM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
SOMANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Information 1
Total Device Problems 1

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 0 1 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 Nonin Medical, Inc II Nov-25-2009

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