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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device meter, peak flow, spirometry
Product CodeBZH
Regulation Number 868.1860
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING M&B ELECTRONIC INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BESMED HEALTH BUSINESS CORP.
  SUBSTANTIALLY EQUIVALENT 1
BREATHE ME LTD
  SUBSTANTIALLY EQUIVALENT 1
DYNAMITECH MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
GOSTAR CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU HOMESUN MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
K-JUMP HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KNOX MEDICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIR MEDICAL INTERNATIONAL RESEARCH
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
NOBLE MARKETING
  SUBSTANTIALLY EQUIVALENT 1
SAFEY MEDICAL DEVICES PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SONMOL MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPARO INC.
  SUBSTANTIALLY EQUIVALENT 1
TAIAN DALU MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIASYS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 22 22
2015 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 22 22
Sticking 8 8
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 22 22
No Known Impact Or Consequence To Patient 1 1

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