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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oximeter, reprocessed
Definition same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNLF
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL INSTRUMENT AND SAVINGS INC (DBA MEDLINE RENEWAL)
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K191018  Medline ReNewal Reprocessed Masimo LNCS Series Adu ...

MDR Year MDR Reports MDR Events
2019 11 11
2020 2 2
2021 1 1
2022 2 2
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 4 4
Temperature Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Patient Device Interaction Problem 2 2
Adhesive Too Strong 2 2
Defective Component 2 2
Device Sensing Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Separation 1 1
Material Protrusion/Extrusion 1 1
Packaging Problem 1 1
Break 1 1
No Device Output 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
Skin Inflammation/ Irritation 4 4
Inflammation 3 3
Burn(s) 2 2
Confusion/ Disorientation 1 1
Insufficient Information 1 1
Numbness 1 1
Injury 1 1

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