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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pressure monitoring (air/gas) kit
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodePXE
Regulation Number 868.2610
Device Class 1

MDR Year MDR Reports MDR Events
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Readings 2 2
Low Readings 2 2
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3

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