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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2024
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Device
analyzer, gas, oxygen, gaseous-phase
Product Code
CCL
Regulation Number
868.1720
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIO-MED DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
CAREOX, LLC
SUBSTANTIALLY EQUIVALENT
1
MAXTEC, LLC
SUBSTANTIALLY EQUIVALENT
1
1. K221734
Maxtec MaxO2 ME+p
MDR Year
MDR Reports
MDR Events
2019
1
1
2020
1
1
2021
3
3
2023
4
4
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
1
1
Off-Label Use
1
1
Insufficient Information
1
1
Defective Device
1
1
Material Integrity Problem
1
1
Failure to Deliver
1
1
Improper Flow or Infusion
1
1
Inaccurate Flow Rate
1
1
Insufficient Flow or Under Infusion
1
1
Partial Blockage
1
1
Incorrect Measurement
1
1
Device Sensing Problem
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7
7
Insufficient Information
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Known Impact Or Consequence To Patient
1
1
Discomfort
1
1
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