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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
Regulation Description Fetal ultrasonic monitor and accessories.
Product CodeKNG
Regulation Number 884.2660
Device Class 2


Premarket Reviews
ManufacturerDecision
CONTEC MEDICAL SYSTEMS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN BESTMAN INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JAMR TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MERICONN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN TAIKANG MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHONGSHAN XIAOLAN TOWN SENLAN ELECTRONIC FACTORY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 1 1
2023 2 3
2024 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 3 3
Skin Burning Sensation 1 2
Electric Shock 1 1
Hemorrhage/Blood Loss/Bleeding 1 1

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