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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, ultrasonic, fetal
Product CodeKNG
Regulation Number 884.2660
Device Class 2


Premarket Reviews
ManufacturerDecision
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HERAMED LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MERICONN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN TAIKANG MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZZHEN LUCKCOME TECHNOLOGY INC., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VCOMIN TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 2 2
Use of Device Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 1 1
Cramp(s) 1 1
Electric Shock 1 1
Skin Burning Sensation 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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