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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device spirometer, monitoring (w/wo alarm)
Regulation Description Monitoring spirometer.
Product CodeBZK
Regulation Number 868.1850
Device Class 2


Premarket Reviews
ManufacturerDecision
RESPIRATORY MOTION, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Mindray DS USA, Inc. dba Mindray North America III Mar-28-2018

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